- Email: [email protected]
Ice Packs Reduce Postoperative Midline Incision Pain and Narcotic Use: A Randomized Controlled Trial
Accepted Manuscript Ice Packs Reduce Postoperative Midline Incision Pain and Narcotic Use: A Randomized Controlled Trial Ammara A. Watkins , MD Timothy V. Johnson , MD Adam B. Shrewsberry , MD Paymon Nourparvar , MD Tarik Madni , MD Colyn J. Watkins , MD Paul L. Feingold , MD David A. Kooby , MD, FACS Shishir K. Maithel , MD, FACS Charles A. Staley , MD Viraj A. Master , MD, PhC, FACS PII:
S1072-7515(14)00412-8
DOI:
10.1016/j.jamcollsurg.2014.03.057
Reference:
ACS 7411
To appear in:
Journal of the American College of Surgeons
Received Date: 26 January 2014 Revised Date:
23 February 2014
Accepted Date: 25 March 2014
Please cite this article as: Watkins AA, Johnson TV, Shrewsberry AB, Nourparvar P, Madni T, Watkins CJ, Feingold PL, Kooby DA, Maithel SK, Staley CA, Master VA, Ice Packs Reduce Postoperative Midline Incision Pain and Narcotic Use: A Randomized Controlled Trial, Journal of the American College of Surgeons (2014), doi: 10.1016/j.jamcollsurg.2014.03.057. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Ice Packs Reduce Postoperative Midline Incision Pain and Narcotic Use: A Randomized Controlled Trial
RI PT
Ammara A Watkins, MD1, Timothy V Johnson, MD2, Adam B Shrewsberry, MD1, Paymon Nourparvar, MD1, Tarik Madni, MD1, Colyn J Watkins, MD1, Paul L Feingold, MD1, David A
Master, MD, PhC, FACS1,3 [C.E. 11 authors are okay, per Editorial Office]
SC
Kooby, MD, FACS3,4, Shishir K Maithel, MD, FACS3,4, Charles A Staley, MD 3,4, Viraj A
Emory University, Atlanta, GA.
M AN U
Dept. of Urology1, Division of Surgical Oncology3, and Department of Surgery4
Wills Eye Institute,2 Thomas Jefferson University, Philadelphia, PA.
TE D
Disclosure Information: Nothing to disclose.
Abstract presented at the American College of Surgeons 99th Annual Clinical Congress, Surgical Forum, Washington, DC, October 2013.
EP
Running head: Ice Packs Minimize Narcotic Use
AC C
Correspondence address: Viraj A. Master MD, PhD, FACS 1364 Clifton Road Atlanta, GA 30322 404-778-7777 [email protected]
ACCEPTED MANUSCRIPT
Abstract Background: Postoperative pain is an unavoidable consequence of open abdominal surgery. Although cryotherapy, the application of ice to a surgical wound site, has been shown to be
RI PT
effective in reducing postoperative pain in orthopedic, gynecologic, and hernia operations, it has not been assessed in patients who undergo major open abdominal operations. We hypothesized that patients who receive cryotherapy would report lower pain scores as a primary outcome
SC
measure.
Study Design: Patients undergoing abdominal operations with midline incisions were
M AN U
randomized to receive cryotherapy for a minimum of 24 hours in time intervals dictated by patient preference vs. no cryotherapy. The primary outcome of pain relief was assessed with visual analog pain scores (VAS). The study was powered to detect a clinically significant difference in VAS between the control and cryotherapy group. Comparisons between groups
TE D
were measured by Student's t- or Mann-Whitney U test for parametric and non-parametric data, respectively.
Results: 55 patients were randomized, 28 to the control group and 27 to the cryotherapy group.
EP
For the primary measure, mean postoperative pain score on postoperative day one and three after surgery was significantly lower between the control and cryotherapy group on the visual analog
AC C
pain scale (P-value < 0.005). Narcotic use was decreased in the cryotherapy group on POD1 by 3.9 morphine equivalents (P-value 0.008). No statistically significant difference was found between the two treatment groups with respect to length of hospital stay, pulmonary complications, and wound infection rate in terms of secondary measures. Conclusions: Ice packs are a simple, cost effective adjuvant for decreasing postoperative pain and narcotic use in patients undergoing major abdominal operations.
2
ACCEPTED MANUSCRIPT
Introduction
Pain is an unavoidable side effect of all major abdominal operations. It arises from local
RI PT
inflammation in traumatized tissues and causes stimulation of the surrounding nocicepters.1-6 Even the most minor of surgical wounds induce inflammation and pain during the healing
process.3 Adequate postoperative analgesia prevents chronic pain and is essential for patient
SC
recovery, mobility, and satisfaction. While narcotic medication is critical in postoperative pain management, multimodal analgesia is increasingly preferred, given the numerous dose dependent
M AN U
side effects of narcotics. 1,2,6-16
A relatively non-invasive and cost-effective technique targeting inflammation is cryotherapy, the application of cold modalities to decrease pain secondary to trauma, injury, or disease.15-28
TE D
Cryotherapy has few deleterious side effects due to its non-pharmalogic nature and has become widespread in sports medicine to treat soft tissue damage. 7,17,20,22,23,25 It has also been shown to reduce post-operative pain and recovery time after various surgeries, including inguinal hernia
EP
repair. 14,19,21,26,27
AC C
Patients, health care teams, and insurers are looking for cost effective strategies for reducing postoperative use of narcotics. We felt it prudent to further investigate cryotherapy’s potential as a postoperative analgesic for major abdominal operations. We hypothesized that patients undergoing major abdominal operations and randomized to receive cryotherapy via an ice pack in the immediate postoperative period would report lower pain scores, use less narcotic pain medications, and have shorter hospital stays.
3
ACCEPTED MANUSCRIPT
Methods
RI PT
Patient Population
Seventy-seven patients were enrolled between May 2008 and March 2011. Inclusion criteria included any open transperitoneal abdominal surgery with a classic midline incision.
SC
Patients were excluded from the study if the patient underwent a minimally invasive operation instead of an “open” operation. Patients were also excluded if they underwent reoperation during
M AN U
this hospital stay. On-Q Painbuster pumps (Lake Forest, CA), epidural catheters, Ketoralac, intraoperative local analgesia, and Lidocaine patches were not used as exclusion criteria. There were no deviations from study design. No patients crossed over to the alternate study arm, nor were any lost to follow up. The Emory University Institutional Review Board approved this
TE D
protocol, and written informed consent was obtained from all participants prior to inclusion into the study registry.
EP
Randomization and cryotherapy administration
AC C
Patients were randomized preoperatively using a random number generator. All staff and patients were blinded to randomization until the completion of the surgery. Due to the nature of ice packs, postoperative blinding of patients and staff to group allocation was not possible. Cryotherapy was applied via reusable ice bags filled with ice. Ice packs were made of opaque synthetic material with a clamp closure (Figure 1). The attending surgeon notified the study coordinator, who was not involved in the clinical care of the patient, at the completion of each
4
ACCEPTED MANUSCRIPT
operation. If a patient was in the cryotherapy arm, an ice pack was brought to the operating suite by the study coordinator. Ice packs were immediately applied after the dressing was placed on the wound. The ice pack was maintained in place for a continuous twenty-four hours and was
RI PT
refilled multiple times throughout the day as needed by ancillary staff and the research
coordinator. After twenty-four hours, patients had the option of using ice packs for as long as they wished. The duration of ice pack usage was noted. Intention to treat analysis was conducted
M AN U
Outcome Measures
SC
regardless of length of cryotherapy application after randomization.
Primary outcome measure was pain score on postoperative days 0-3. Patients were instructed to rate and record pain intensity on a continuous 10-cm visual analog pain scale (VAS), in which 0
TE D
represented no pain and 10 equated with the worst pain imaginable.29 Patients were asked to complete a visual analog score one hour postoperatively and then at 8:00AM and 4:00PM each
EP
day.
Secondary outcomes included narcotic utilization and length of hospital stay. Narcotic use was
AC C
documented throughout the day using patient charts and confirmed with the patient’s nursing team. All narcotic use was documented and converted to morphine equivalents using an equianalgesic table provided by the Emory University Department of Palliative Care. Colleagues in the Department of Anesthesiology and Pharmacology confirmed accuracy of the equianalgesic table. Patients were also asked to complete a voluntary questionnaire assessing their tolerance
5
ACCEPTED MANUSCRIPT
and experience with using the ice packs. Nurses were also given a questionnaire assessing their views on patient comfort and ease with using the ice pack.
RI PT
Statistical analysis
Power calculations indicated a requirement for 27 patients per research arm. In part, this
calculation was based on prior publications which looked at the difference in VAS score to result
SC
in a change in perception of pain by patients.30-33 A sample of 27 patients per group was required
of significance and a power of 90 percent.
M AN U
to detect a 15% difference in pain score between the two groups on a VAS, assuming a 0.05 level
Descriptive analyses were conducted on demographic, clinical, and surgical variables. Other than gender (expressed as % male), data were expressed as a mean and standard deviation (SD).
TE D
Comparisons between the randomized groups were achieved using an independent sample, twotailed t-test or Mann-Whitney U test for parametric and non-parametric data, respectively. A Pvalue of 0.05 was used as the level of significance. The results were analyzed using the
AC C
EP
Statistical Package for Social Science for Windows version 18 (SPSS Inc., Chicago, IL, USA).
Results
Of the 77 patients enrolled in the study, 55 patients fit inclusion criteria. Twenty-eight patients were randomized to the control group and 27 patients were randomized to receive ice packs after their operation (figure 2). There were no statistical differences in any of the baseline preoperative characteristics (age, gender, BMI, narcotic use, and pain score between the two
6
ACCEPTED MANUSCRIPT
groups (Table 1). The majority of operations (76%) were for pancreatic, gastric, liver, and colorectal cancers; the remaining operations were for renal, bladder, and prostate cancer. All were completed through a midline incision. There was no statistical difference between the two
RI PT
groups in terms of incision length, additional incisions for drains, or Marcaine infiltrated into the wound (Table 2). Further, the two groups did not differ in terms of use of epidurals, PCA, On Q pumps, or Lidocaine patches (Table 3). Procedures included exploratory laparotomy,
SC
pancreaticoduodenectomy, gastrectomy, esophagectomy, liver resection, small bowel resection, retroperitoneal lymph node dissection, colorectal resection, intraperitoneal chemotherapy,
M AN U
cystectomy, partial or complete nephrectomy, intraperitoneal chemotherapy with tumor debulking, and open uerterolysis. There was no intraoperative administration of NSAIDs or Acetaminophen in either group.
TE D
There was no difference between postoperative pain scores one hour after surgery between the two groups (p=0.588). The distribution of postoperative pain scores between the control and cryotherapy group was lower for patients receiving cryotherapy in the AM and PM on POD1 and
EP
in the PM on POD3 (Figure 3). Total narcotic use in morphine equivalents was lower on POD1 in the cryotherapy group (Figure 4). There was no difference in length of hospital stay between
AC C
the two groups (Table 4).
Patients in the cryotherapy arm used ice packs for a mean of 2.75 days (SD 1.86). No patient in the experimental arm requested the ice pack to be removed within the first 24 hours due to discomfort, nor did any patient experience a thermal injury associated with the ice pack. Anecdotally some patients complained of shivering or the ice pack being too cold, but felt that
7
ACCEPTED MANUSCRIPT
the temperature was well controlled once nursing staff provided blankets. There was no incidence of hypothermia noted in patient vital signs in the cryotherapy group. There was no statistically significant difference between postoperative pulmonary or wound complications
RI PT
when comparing the two groups. Documentation of ileus was equal in both groups (Table 4).
Twenty-one out of 27 patients in the cryotherapy arm completed a voluntary questionnaire on
SC
patient satisfaction about ice packs. The majority of patients (81%, N=17) cited that the ice pack provided pain relief to their postoperative pain. Sixteen (76%) patients stated they would request
M AN U
an ice pack for postoperative pain management if they had another surgery. Comments from patients regarding the ice packs included, “The ice packs helped me a lot,” “it reduced the swelling,” and “my pain was worse when the ice pack was off.”
TE D
Ten nurses completed the questionnaire on ice pack administration. One nurse stated that they had used ice packs on surgical wounds prior to our study for pain management. Eighty percent of nurses felt that ice packs could provide patients with either moderate to significant relief. Only
EP
one nurse of the cohort felt that her patients had no pain relief with the ice packs. Six out of ten nurses stated they would request an ice pack if they underwent abdominal surgery for additional
AC C
pain relief.
Discussion
We performed a randomized control trial assessing the impact of cryotherapy (ice packs) on pain control, narcotic use, and length of stay for patients undergoing a midline laparotomy incision. The simple maneuver of placing an ice pack on the incision reduces postoperative pain and
8
ACCEPTED MANUSCRIPT
decreases the use of narcotics in the first 24 hours. Cryotherapy should be complementary to other pain management strategies because it is easy, affordable, well received by patients, and has minimal to no toxicity. This is particularly important in the geriatric patient population that is
RI PT
increasingly sensitive to narcotic side effects.
Cryotherapy has been shown to reduce postoperative pain in studies conducted by other surgical
SC
subspecialties: otolaryngology, orthopedics, obstetrics, ophthalmology, and plastics.31-44 A
Cochrane Review of local cooling to reduce perineal trauma sustained during childbirth has
M AN U
some evidence for the safe and effective use of cryotherapy. The review looked at ten studies including 1825 women that compared multiple cooling therapies such as ice, ice gel packs, cold baths, and cold packs to the area. 43 One study did show that women had lower pain scores at 24
TE D
and 72 hours post-birth when ice packs were used. 44
Cryotherapy’s mechanism of action is multifold. It reduces inflammation and swelling which facilitates oxygenation of cells.15,16,19,20,21,24,27 Cryotherapy also slows the cell’s metabolic rate,
EP
thereby reducing oxygen demand in an environment of reduced oxygen accessibility.15,16 Its suppression of exotoxins also limits tissue damaging free radicals. Additionally, cryotherapy can
AC C
prevent neural plasticity and chronic pain by decreasing free nerve ending sensitivity, increasing nerve firing thresholds, and slowing synaptic activity.24,27,28 These neural effects increase a patient’s pain threshold and can diminish the need for pharmacologic intervention, via narcotics or local anesthetics, for example.19,20,28
9
ACCEPTED MANUSCRIPT
There is a dearth of studies focusing on cryotherapy’s effect on abdominal incisions. Furthermore, the data that is available has a paucity of randomized control trials. In our study, a change in the VAS was evident on POD1 and PO3 with cryotherapy. While the absolute
RI PT
numbers are small, the changes are perceptible to patients. Pain was reduced on POD1 when virtually all patients in the ice pack arm were using their ice packs on a regular basis. For less clear reasons it was also reduced on POD3, but not on POD2. Possible reasons for this include
SC
increased ambulation and mobility by patients on POD2, which can cause increased pain and perhaps less usage of ice packs. Postoperative cryotherapy appears to be most effective on POD1
M AN U
following an abdominal operation. Certainly, it is an inexpensive addition, with each refillable ice pack costing less than $2.00. This is particularly ideal in resource-constrained environments such as the developing world. As demonstrated by 76% of patients in the cryotherapy arm stating they would request ice in future operations, the majority of patients were satisfied with ice packs
TE D
being added to their postoperative pain management plan.
Our study showed a statistical difference in narcotic use within the first 24 hours following
EP
discharge form the PACU, in the POD1 time period. One reason why decreased narcotic use was not noted in the ice arm on subsequent postoperative days may have been because the average
AC C
length of use for ice packs was 2.81 days (SD 2.24) which included the day of surgery as day 1. Ice works locally and for a short period of time following its removal. It is logical that we did not see reduced amount of narcotic use in subsequent days when patients were no longer using ice packs. Perhaps if patients had used the ice packs for longer, narcotic use would have been lower in subsequent days. All patients in the cryotherapy arm received ice pack placement for 24 hours. They were told to continue using ice packs per their preference. A longer duration of cryotherapy
10
ACCEPTED MANUSCRIPT
may have a durable effect on decreased narcotic usage, but needs to be studied separately. There is already some evidence for cryotherapy’s ability to reduce narcotic use, particularly in the orthopedic literature.34-38 Our study affirms that cryotherapy can reduce postoperative narcotic
RI PT
use in patients undergoing major abdominal operations.
There was no statistical difference in length of stay between the control and cryotherapy group.
SC
Liver, pancreatic, colon, renal, and pelvic resections were fairly equivalent between groups. Diagnostic exploratory laparotomies due to intraoperative metastasis or non-resectable disease
M AN U
were also equivalent. It is unclear why length of stay did not differ between the two groups. One explanation is that morphine equivalents were not reduced to a clinically significant level between the two groups. Theoretically there should be an effect given the improved pain control and decreased narcotic use. Su et al showed that a cryopneumatic device reduced narcotic use
TE D
two weeks post discharge as well as improved distance of ambulation in patient’s undergoing total knee arthoplasty.31 We did not study early ambulation, time to bowl function, Tordaol use, or use of narcotics following discharge, but these outcomes would be important to review in
EP
subsequent studies. Retrospective review of these variables was attempted but documentation was not consistent among the available records. Ileus was, however, equally documented in both
AC C
the cryotherapy and control group on retrospective review.
The study has a several limitations. Double blinding is impossible due to the nature of ice packs, which allow patients and staff to be readily aware of its presence. Patients were therefore only blinded prior to their operation. The nature of ice packs also prevented the use of a placebo. A placebo room temperature filled pouch was considered during trial design, however, our team
11
ACCEPTED MANUSCRIPT
felt that this would not qualify as a true placebo as patients and providers would know it is at room temperature. Additionally, our study design asked patients to fill out the visual analog pain scale twice a day at regular intervals rather than average their pain over the day. Future studies
RI PT
may also utilize gel packs instead of ice bags to minimize leakage, which was a rare occurrence in our group. We chose not to use gel packs because of the increased cost to the patient.
It is also possible that there may have been a positive compression effect as seen with abdominal
SC
binders, which may have impacted pain relief. A filled ice pack weights approximately 1.5 pounds which is similar to a cough pillow. The compressive effect could be studied in the future
M AN U
by comparing pain control of a cough pillow versus an ice pack. However, there is sound evidence in the literature that cryotherapy decreases cell metabolic demands and reduces inflammation. Anecdotally, ice packs are better tolerated than binders, especially by women who often complain of discomfort along their breasts. In terms of cost, ice packs cost less than
TE D
abdominal binders (less than $2 versus greater than $20). The compressive effects of a binder and an ice pack are also different with the binder distributing pressure with greater strength and over a larger surface area. Use of a binder with an ice pack may have a synergistic effect that
EP
should be studied further.
AC C
Patients in this trial underwent a variety of operations. Future studies on the topic should assess the efficacy of ice packs on a standardized operation to minimize confounders (open pylorus preserving pancreaticoduodenectomy for example). As with all studies, it is possible we did not account for all differences and there may be unconsidered confounders. Finally, it would be interesting to study systemic levels of inflammatory markers among patients provided with postoperative ice packs.
12
ACCEPTED MANUSCRIPT
Conclusion Ice packs are a simple, cost-effective adjuvant to standard postoperative pain management. Although ice pack use does not affect hospital stay in surgical patients, it does significantly
RI PT
reduce postoperative midline incisional pain and narcotic use in patients undergoing major open
AC C
EP
TE D
M AN U
SC
abdominal surgery.
13
ACCEPTED MANUSCRIPT
References 1. Reuben SS, Eckman EF. The effect of initiating a preventive multimodal analgesic regimen on long-term patient outcomes for outpatient anterior cruciate ligament reconstruction surgery.
RI PT
Anesth Analg 2007;105:19-20.
2. Holder KA, Dougherty TB, Porche VH et al. Postoperative pain management. Int Anesthesiol Clin 1998;36:71-86.
SC
3. Pelissier EP. [How can pain of surgery be limited?] Ann Fr Anesth Reanim 1998;17:613-621.
2007;11:5-13.
M AN U
4. Reuben SS. Chronic pain after surgery: what can we do to prevent it. Curr Pain Headache Rep
5. Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology 2000;93:1123-1133.
6. Reuben SS, Buvanendran M. Preventing the development of chronic pain after orthopaedic
TE D
surgery with preventive multimodal analgestic tehniques. J Bone Joint Surg Am 2007;89:13431358.
7. Reuben SS, Eckman EF Charron D. Evaluating the analgesic efficacy of administering
EP
celecoxib as a component of multimodal analgesia for outpatient anterior cruciate ligament reconstruction surgery. Anesth Analg 2007;105:19-20.
AC C
8. Michaloliakou C, Chung F, Sharma S. Preoperative multimodal analgesia facilitates recovery after ambulatory laparoscopic recovery after ambulatory laparoscopic cholecystectomy. Anesth Analg 1996;82:44-51.
9. Schumacher MA, Basabaum AI. Chapter 31. Opiod analgesics and antagonists. In: Katsung B, Master S, Trevor A, eds. Basic and Clinical Pharmacology. 11th ed. San Francisco: McGrawHill 2009.
14
ACCEPTED MANUSCRIPT
10. Wheeler M, Oderda G, Ashburn M, Lipman A. Adverse events associated with postoperative opiod analgesia; a systemic review. J Pain 2002;3:159-180. 11. Faboya A, Uncles D. Post Caesarean delivery pain management: multimodal approach. Int J
RI PT
Obstet Anesth 2007;15:185-186.
12. Mitchinson AR, Kim H, Rosenberg JM, et al. Acute postoperative pain management using massage as an adjuvant therapy: a randomized trial. Arch Surg 2007;142:1158-1167.
SC
13. Raue W, Haase O, Junghans T, et al. 'Fast-track' multimodal rehabilitation program improves outcome after laparoscopic sigmoidectomy: a controlled prospective evaluation. Surg Endosc
M AN U
2004;18:1463-1468.
14. Kwekkeboom KL. Pain management strategies used by patients with breast and gynecologic cancer with postoperative pain. Cancer Nurs 2001;24:378-386.
15. Nalder SF, Weingand K, Kruse RJ. The physiologic basis and clinical applications of
TE D
cryotherapy and thermotherapy for the pain practitioner. Pain Physician 2004;7:395-399. 16. Muldoon J. Skin cooling, pain and chronic wound healing progression. Br J Community Nurs 2006;11:S24-S25.
Nurs 1994;13:21-30.
EP
17. McDowell JH, McFarland EG, Nalli BJ. Use of cryotherapy for orthopaedic patients. Orthop
AC C
18. Hirvonen HE, Mikkelsson MK, Kautiainen H, et al. Effectiveness of different cryotherapies on pain and disease activity in active rheumatoid arthritis. a randomized single blinded controlled trial. Clin Exp Rheumatol 2006;24:295-301. 19. Evans PJ. Cryoanalgesia. The application of low temperatures to nerves to produce anaesthesia or analgesia. Anaesthesia 1981;36:1003-1013.
15
ACCEPTED MANUSCRIPT
20. Swenson C, Swärd L, Karlsson J. Cryotherapy in sports medicine. Scand J Med Sci Sports 1996;6:193-200. 21. Greenstein G. Therapeutic efficacy of cold therapy after intraoral surgical procedures: a
RI PT
literature review. J Peridontol 2007;78:790-800.
22. Hubbard TJ, Denegar CR. Does cryotherapy improve outcomes with soft tissue injury? J Athl Train 2004;39:278-279.
SC
23. Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft tissue injury: a systemic review of randomized controlled trials. Am J Sports Med 2004;32:251-261.
M AN U
24. Ernst E, Fialka V. Ice freezes pain? a review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage 1994;9:56-59.
25. Meeusen R, Lievens P. The use of cryotherapy in sports medicine. Sports Med 1986;3:398414.
TE D
26. Koc M, Tez M, Yoldas O, et al. Cooling for the reduction of postoperative pain: prospective randomized study. Hernia 2006;10:184-186.
27. Kerschan-Schinl K, Uher EM, Zauner-Dungl A, Fialka-Moser V. [Cold and cryotherapy. a
1998;25:73-78.
EP
review of the literature on general principles and practical applications.]. Acta Medica Austriaca
AC C
28. Butterworth JF 4th, Walker FO, Neal JM. Cooling potentiates lidocaine inhibition of median nerve sensory fibers. Anesthesia Analgesia 1990;70:507-511. 29. DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analogue scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg 1998;86:102–106
16
ACCEPTED MANUSCRIPT
30. van der Westhuijzen A, Becker P, Morkel J, Roelse J. A randomized observer blind comparison of bilateral facial ice pack therapy with no ice pack therapy following third molar surgery. Int J Oral Maxillofac Surg 2005;34:281-286
RI PT
31. Su EP, Perna M, Boettner F, et al. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasy recovery. J Bone Join Surg Br 2012; 94: 153-156.
SC
32. Sarifakioglu N, Sarifakioglu E. Evaluating the effects of ice application on the pain felt
Ann Plast Surg 2004; 543-546.
M AN U
during botulinum toxin type-a injections: a prospective, randomized, single-blind controlled trial.
33. Akan M, Misirlioglu A, Yildirim S, et al. Ice application to minimize pain in the splitthickness skin graft donor site. Aesthetic Plast Surg 2003; 305-307. 34. Waterman B, Walker JJ, Swaims C, et al. The efficacy of combined cryotherapy and
TE D
compression compared with cryotherapy alone following anterior cruciate ligament construction. J Knee Surg 2012; 25:155-160.
35. Fang L, Hung CH, Wu SL, et al. The effects of cryotherapy in relieving postarthroscopy
EP
Pain. J Clin Nurs 2012; 21: 636-643.
36. Scheffler NM, Sheitel PL, Lipton MN. Use of cryo/cuff for the control of postoperative pain
AC C
and edema. J Foot Surg 1992; 31: 141-148. 37. Cohn BT, Draeger RI, Jackson DW. The effects of cold therapy in the postoperative management of pain in patients undergoing anterior cruciate ligament reconstruction. Am J Sports Med 1998; 17:344-349. 38. Whitelaw GP, DeMuth KA, Demos HA, et al. The use of cryo/cuff versus ice and elastic wrap in the postoperative care of knee arthroscopy patients. Am J Knee Surg 1995;8:28-30.
17
ACCEPTED MANUSCRIPT
39. Rotenberg BW, Wickens B, Parnes J. intraoperative ice pack application for uvulopalatoplasty pain reduction: a randomized controlled trial. Laryngoscope 2013; 123: 533536.
sustained during childbirth. Cochrane Database Syst Rev. 2012;16.
RI PT
40. East CE, Begg L, Henshall NE, et al. Local cooling for relieving pain from perineal trauma
41. Forouzanfar T, Sabelis A, Ausems S, et al. Effect of ice compression on pain after
SC
mandibular third molar surgery: a single blind, randomized controlled trial. Int J Oral Maxillofac Surg 2008; 824-830.
for lid surgery. Orbit 2006; 107-110.
M AN U
42. Goel S, Chang B, Bhan K, et al. “Cryoanalgesic preparation” before local anesthetic injection
43. East CE, Begg L, Henshall NE, et al. Local cooling for relieving pain from perineal trauma sustained during childbirth (Review). Cochrane Database Syst Rev 2012;9.
TE D
44. Finan MA, Roberts MS, Florica JV, et al. The effects of cold therapy on postoperative pain in
AC C
EP
gynecologic patients: a prospective, randomized study. Am J Obstet Gynecol 1993; 168:542-544.
18
ACCEPTED MANUSCRIPT
Table 1. Preoperative Patient Characteristics
RI PT
p Value 0.160 1.96 0.324 0.609 0.256
AC C
EP
TE D
M AN U
SC
Value Age, mean (SD) Sex, % male BMI, kg/m2, mean (SD) Preoperative narcotic use, n Preoperative pain score, mean (SD)
Randomization Ice Control 62.2 (13.7) 57.0 (12.7) 53.8% 62.1% 25.9 (5.3) 27.2 (4.5) 3 2 0.1 (0.5) 0.7 (1.8)
19
ACCEPTED MANUSCRIPT
Table 2. Operative Characteristics
12.4 (26.6)
RI PT
14.6 (29)
p Value 0.453 0.335 0.982
AC C
EP
TE D
M AN U
SC
Value Incision length, cm, mean (SD) Combined length of additional incisions, mean (SD) 0.25 Marcaine equivalents injected into wound in mL, mean (SD)
Randomization Ice Control 18.7 (7.9) 20.2 (6.2) 0.3 (0.6) 0.3 (0.6)
20
ACCEPTED MANUSCRIPT
Table 3. Postoperative pain management characteristics Randomization, n (%) Ice Control 13 (48.1) 8 (28.6) 7 (25.9) 10 (35.7) 0 (0) 3 (11.1) 4 (14.8) 3 (10.7)
RI PT
p Value 0.171 0.565 0236 0.699
AC C
EP
TE D
M AN U
SC
Value PCA Epidural On Q pump Lidocaine patch
21
ACCEPTED MANUSCRIPT
Table 4. Postoperative Characteristics Randomization Ice Control 6.5 (2.9) 5.7 (3.3) 6 4 3 1 2 2
RI PT
p Value 0.367 0.528 0.193 1.00
AC C
EP
TE D
M AN U
SC
Value Hospital stay, d, mean (SD) Pulmonary complications Wound infection Ileus
22
ACCEPTED MANUSCRIPT
Figure Legends
Figure 2. Flow chart of participants’ progress through the study.
RI PT
Figure 1. Standard icepack placed on a midline incision.
SC
Figure 3. Self-reported pain by time for patients in the cryotherapy and control study arms. Pain was measure using a visual analog scale. Pain measurements were taken preoperatively,
M AN U
perioperatively in the postanesthesia care unit, and twice daily during each postoperative day. Self-reported pain among ice and control patients was significantly different on POD 1 AM (p=0.042), POD 1 PM (p=0.001), and POD 3 PM (p=0.039). *Statistically significant (p < 0.05). Blue bar, cryotherapy; red bar, control.
TE D
Figure 4. Morphine equivalents of narcotic usage. Equivalents were calculated in the postanesthesia care unit (p= 0.117), and then daily in 24 hours (POD1, p=0.008), 48 hours
EP
(POD2, p=0.0164 ), and 72 hours (POD3, p=0.111) hours postoperatively. *Statistically
AC C
significant (p < 0.05). Blue bar, cryotherapy; red bar, control.
23
ACCEPTED MANUSCRIPT
Precis Fifty-five patients undergoing major abdominal operations were randomized to receive cryotherapy (ice packs) vs no cryotherapy to midline incisions. This simple intervention reduced
AC C
EP
TE D
M AN U
SC
RI PT
pain scores on postoperative day 1 and 3 and narcotic use on postoperative day 1.
24
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
S1072-7515(14)00412-8
DOI:
10.1016/j.jamcollsurg.2014.03.057
Reference:
ACS 7411
To appear in:
Journal of the American College of Surgeons
Received Date: 26 January 2014 Revised Date:
23 February 2014
Accepted Date: 25 March 2014
Please cite this article as: Watkins AA, Johnson TV, Shrewsberry AB, Nourparvar P, Madni T, Watkins CJ, Feingold PL, Kooby DA, Maithel SK, Staley CA, Master VA, Ice Packs Reduce Postoperative Midline Incision Pain and Narcotic Use: A Randomized Controlled Trial, Journal of the American College of Surgeons (2014), doi: 10.1016/j.jamcollsurg.2014.03.057. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Ice Packs Reduce Postoperative Midline Incision Pain and Narcotic Use: A Randomized Controlled Trial
RI PT
Ammara A Watkins, MD1, Timothy V Johnson, MD2, Adam B Shrewsberry, MD1, Paymon Nourparvar, MD1, Tarik Madni, MD1, Colyn J Watkins, MD1, Paul L Feingold, MD1, David A
Master, MD, PhC, FACS1,3 [C.E. 11 authors are okay, per Editorial Office]
SC
Kooby, MD, FACS3,4, Shishir K Maithel, MD, FACS3,4, Charles A Staley, MD 3,4, Viraj A
Emory University, Atlanta, GA.
M AN U
Dept. of Urology1, Division of Surgical Oncology3, and Department of Surgery4
Wills Eye Institute,2 Thomas Jefferson University, Philadelphia, PA.
TE D
Disclosure Information: Nothing to disclose.
Abstract presented at the American College of Surgeons 99th Annual Clinical Congress, Surgical Forum, Washington, DC, October 2013.
EP
Running head: Ice Packs Minimize Narcotic Use
AC C
Correspondence address: Viraj A. Master MD, PhD, FACS 1364 Clifton Road Atlanta, GA 30322 404-778-7777 [email protected]
ACCEPTED MANUSCRIPT
Abstract Background: Postoperative pain is an unavoidable consequence of open abdominal surgery. Although cryotherapy, the application of ice to a surgical wound site, has been shown to be
RI PT
effective in reducing postoperative pain in orthopedic, gynecologic, and hernia operations, it has not been assessed in patients who undergo major open abdominal operations. We hypothesized that patients who receive cryotherapy would report lower pain scores as a primary outcome
SC
measure.
Study Design: Patients undergoing abdominal operations with midline incisions were
M AN U
randomized to receive cryotherapy for a minimum of 24 hours in time intervals dictated by patient preference vs. no cryotherapy. The primary outcome of pain relief was assessed with visual analog pain scores (VAS). The study was powered to detect a clinically significant difference in VAS between the control and cryotherapy group. Comparisons between groups
TE D
were measured by Student's t- or Mann-Whitney U test for parametric and non-parametric data, respectively.
Results: 55 patients were randomized, 28 to the control group and 27 to the cryotherapy group.
EP
For the primary measure, mean postoperative pain score on postoperative day one and three after surgery was significantly lower between the control and cryotherapy group on the visual analog
AC C
pain scale (P-value < 0.005). Narcotic use was decreased in the cryotherapy group on POD1 by 3.9 morphine equivalents (P-value 0.008). No statistically significant difference was found between the two treatment groups with respect to length of hospital stay, pulmonary complications, and wound infection rate in terms of secondary measures. Conclusions: Ice packs are a simple, cost effective adjuvant for decreasing postoperative pain and narcotic use in patients undergoing major abdominal operations.
2
ACCEPTED MANUSCRIPT
Introduction
Pain is an unavoidable side effect of all major abdominal operations. It arises from local
RI PT
inflammation in traumatized tissues and causes stimulation of the surrounding nocicepters.1-6 Even the most minor of surgical wounds induce inflammation and pain during the healing
process.3 Adequate postoperative analgesia prevents chronic pain and is essential for patient
SC
recovery, mobility, and satisfaction. While narcotic medication is critical in postoperative pain management, multimodal analgesia is increasingly preferred, given the numerous dose dependent
M AN U
side effects of narcotics. 1,2,6-16
A relatively non-invasive and cost-effective technique targeting inflammation is cryotherapy, the application of cold modalities to decrease pain secondary to trauma, injury, or disease.15-28
TE D
Cryotherapy has few deleterious side effects due to its non-pharmalogic nature and has become widespread in sports medicine to treat soft tissue damage. 7,17,20,22,23,25 It has also been shown to reduce post-operative pain and recovery time after various surgeries, including inguinal hernia
EP
repair. 14,19,21,26,27
AC C
Patients, health care teams, and insurers are looking for cost effective strategies for reducing postoperative use of narcotics. We felt it prudent to further investigate cryotherapy’s potential as a postoperative analgesic for major abdominal operations. We hypothesized that patients undergoing major abdominal operations and randomized to receive cryotherapy via an ice pack in the immediate postoperative period would report lower pain scores, use less narcotic pain medications, and have shorter hospital stays.
3
ACCEPTED MANUSCRIPT
Methods
RI PT
Patient Population
Seventy-seven patients were enrolled between May 2008 and March 2011. Inclusion criteria included any open transperitoneal abdominal surgery with a classic midline incision.
SC
Patients were excluded from the study if the patient underwent a minimally invasive operation instead of an “open” operation. Patients were also excluded if they underwent reoperation during
M AN U
this hospital stay. On-Q Painbuster pumps (Lake Forest, CA), epidural catheters, Ketoralac, intraoperative local analgesia, and Lidocaine patches were not used as exclusion criteria. There were no deviations from study design. No patients crossed over to the alternate study arm, nor were any lost to follow up. The Emory University Institutional Review Board approved this
TE D
protocol, and written informed consent was obtained from all participants prior to inclusion into the study registry.
EP
Randomization and cryotherapy administration
AC C
Patients were randomized preoperatively using a random number generator. All staff and patients were blinded to randomization until the completion of the surgery. Due to the nature of ice packs, postoperative blinding of patients and staff to group allocation was not possible. Cryotherapy was applied via reusable ice bags filled with ice. Ice packs were made of opaque synthetic material with a clamp closure (Figure 1). The attending surgeon notified the study coordinator, who was not involved in the clinical care of the patient, at the completion of each
4
ACCEPTED MANUSCRIPT
operation. If a patient was in the cryotherapy arm, an ice pack was brought to the operating suite by the study coordinator. Ice packs were immediately applied after the dressing was placed on the wound. The ice pack was maintained in place for a continuous twenty-four hours and was
RI PT
refilled multiple times throughout the day as needed by ancillary staff and the research
coordinator. After twenty-four hours, patients had the option of using ice packs for as long as they wished. The duration of ice pack usage was noted. Intention to treat analysis was conducted
M AN U
Outcome Measures
SC
regardless of length of cryotherapy application after randomization.
Primary outcome measure was pain score on postoperative days 0-3. Patients were instructed to rate and record pain intensity on a continuous 10-cm visual analog pain scale (VAS), in which 0
TE D
represented no pain and 10 equated with the worst pain imaginable.29 Patients were asked to complete a visual analog score one hour postoperatively and then at 8:00AM and 4:00PM each
EP
day.
Secondary outcomes included narcotic utilization and length of hospital stay. Narcotic use was
AC C
documented throughout the day using patient charts and confirmed with the patient’s nursing team. All narcotic use was documented and converted to morphine equivalents using an equianalgesic table provided by the Emory University Department of Palliative Care. Colleagues in the Department of Anesthesiology and Pharmacology confirmed accuracy of the equianalgesic table. Patients were also asked to complete a voluntary questionnaire assessing their tolerance
5
ACCEPTED MANUSCRIPT
and experience with using the ice packs. Nurses were also given a questionnaire assessing their views on patient comfort and ease with using the ice pack.
RI PT
Statistical analysis
Power calculations indicated a requirement for 27 patients per research arm. In part, this
calculation was based on prior publications which looked at the difference in VAS score to result
SC
in a change in perception of pain by patients.30-33 A sample of 27 patients per group was required
of significance and a power of 90 percent.
M AN U
to detect a 15% difference in pain score between the two groups on a VAS, assuming a 0.05 level
Descriptive analyses were conducted on demographic, clinical, and surgical variables. Other than gender (expressed as % male), data were expressed as a mean and standard deviation (SD).
TE D
Comparisons between the randomized groups were achieved using an independent sample, twotailed t-test or Mann-Whitney U test for parametric and non-parametric data, respectively. A Pvalue of 0.05 was used as the level of significance. The results were analyzed using the
AC C
EP
Statistical Package for Social Science for Windows version 18 (SPSS Inc., Chicago, IL, USA).
Results
Of the 77 patients enrolled in the study, 55 patients fit inclusion criteria. Twenty-eight patients were randomized to the control group and 27 patients were randomized to receive ice packs after their operation (figure 2). There were no statistical differences in any of the baseline preoperative characteristics (age, gender, BMI, narcotic use, and pain score between the two
6
ACCEPTED MANUSCRIPT
groups (Table 1). The majority of operations (76%) were for pancreatic, gastric, liver, and colorectal cancers; the remaining operations were for renal, bladder, and prostate cancer. All were completed through a midline incision. There was no statistical difference between the two
RI PT
groups in terms of incision length, additional incisions for drains, or Marcaine infiltrated into the wound (Table 2). Further, the two groups did not differ in terms of use of epidurals, PCA, On Q pumps, or Lidocaine patches (Table 3). Procedures included exploratory laparotomy,
SC
pancreaticoduodenectomy, gastrectomy, esophagectomy, liver resection, small bowel resection, retroperitoneal lymph node dissection, colorectal resection, intraperitoneal chemotherapy,
M AN U
cystectomy, partial or complete nephrectomy, intraperitoneal chemotherapy with tumor debulking, and open uerterolysis. There was no intraoperative administration of NSAIDs or Acetaminophen in either group.
TE D
There was no difference between postoperative pain scores one hour after surgery between the two groups (p=0.588). The distribution of postoperative pain scores between the control and cryotherapy group was lower for patients receiving cryotherapy in the AM and PM on POD1 and
EP
in the PM on POD3 (Figure 3). Total narcotic use in morphine equivalents was lower on POD1 in the cryotherapy group (Figure 4). There was no difference in length of hospital stay between
AC C
the two groups (Table 4).
Patients in the cryotherapy arm used ice packs for a mean of 2.75 days (SD 1.86). No patient in the experimental arm requested the ice pack to be removed within the first 24 hours due to discomfort, nor did any patient experience a thermal injury associated with the ice pack. Anecdotally some patients complained of shivering or the ice pack being too cold, but felt that
7
ACCEPTED MANUSCRIPT
the temperature was well controlled once nursing staff provided blankets. There was no incidence of hypothermia noted in patient vital signs in the cryotherapy group. There was no statistically significant difference between postoperative pulmonary or wound complications
RI PT
when comparing the two groups. Documentation of ileus was equal in both groups (Table 4).
Twenty-one out of 27 patients in the cryotherapy arm completed a voluntary questionnaire on
SC
patient satisfaction about ice packs. The majority of patients (81%, N=17) cited that the ice pack provided pain relief to their postoperative pain. Sixteen (76%) patients stated they would request
M AN U
an ice pack for postoperative pain management if they had another surgery. Comments from patients regarding the ice packs included, “The ice packs helped me a lot,” “it reduced the swelling,” and “my pain was worse when the ice pack was off.”
TE D
Ten nurses completed the questionnaire on ice pack administration. One nurse stated that they had used ice packs on surgical wounds prior to our study for pain management. Eighty percent of nurses felt that ice packs could provide patients with either moderate to significant relief. Only
EP
one nurse of the cohort felt that her patients had no pain relief with the ice packs. Six out of ten nurses stated they would request an ice pack if they underwent abdominal surgery for additional
AC C
pain relief.
Discussion
We performed a randomized control trial assessing the impact of cryotherapy (ice packs) on pain control, narcotic use, and length of stay for patients undergoing a midline laparotomy incision. The simple maneuver of placing an ice pack on the incision reduces postoperative pain and
8
ACCEPTED MANUSCRIPT
decreases the use of narcotics in the first 24 hours. Cryotherapy should be complementary to other pain management strategies because it is easy, affordable, well received by patients, and has minimal to no toxicity. This is particularly important in the geriatric patient population that is
RI PT
increasingly sensitive to narcotic side effects.
Cryotherapy has been shown to reduce postoperative pain in studies conducted by other surgical
SC
subspecialties: otolaryngology, orthopedics, obstetrics, ophthalmology, and plastics.31-44 A
Cochrane Review of local cooling to reduce perineal trauma sustained during childbirth has
M AN U
some evidence for the safe and effective use of cryotherapy. The review looked at ten studies including 1825 women that compared multiple cooling therapies such as ice, ice gel packs, cold baths, and cold packs to the area. 43 One study did show that women had lower pain scores at 24
TE D
and 72 hours post-birth when ice packs were used. 44
Cryotherapy’s mechanism of action is multifold. It reduces inflammation and swelling which facilitates oxygenation of cells.15,16,19,20,21,24,27 Cryotherapy also slows the cell’s metabolic rate,
EP
thereby reducing oxygen demand in an environment of reduced oxygen accessibility.15,16 Its suppression of exotoxins also limits tissue damaging free radicals. Additionally, cryotherapy can
AC C
prevent neural plasticity and chronic pain by decreasing free nerve ending sensitivity, increasing nerve firing thresholds, and slowing synaptic activity.24,27,28 These neural effects increase a patient’s pain threshold and can diminish the need for pharmacologic intervention, via narcotics or local anesthetics, for example.19,20,28
9
ACCEPTED MANUSCRIPT
There is a dearth of studies focusing on cryotherapy’s effect on abdominal incisions. Furthermore, the data that is available has a paucity of randomized control trials. In our study, a change in the VAS was evident on POD1 and PO3 with cryotherapy. While the absolute
RI PT
numbers are small, the changes are perceptible to patients. Pain was reduced on POD1 when virtually all patients in the ice pack arm were using their ice packs on a regular basis. For less clear reasons it was also reduced on POD3, but not on POD2. Possible reasons for this include
SC
increased ambulation and mobility by patients on POD2, which can cause increased pain and perhaps less usage of ice packs. Postoperative cryotherapy appears to be most effective on POD1
M AN U
following an abdominal operation. Certainly, it is an inexpensive addition, with each refillable ice pack costing less than $2.00. This is particularly ideal in resource-constrained environments such as the developing world. As demonstrated by 76% of patients in the cryotherapy arm stating they would request ice in future operations, the majority of patients were satisfied with ice packs
TE D
being added to their postoperative pain management plan.
Our study showed a statistical difference in narcotic use within the first 24 hours following
EP
discharge form the PACU, in the POD1 time period. One reason why decreased narcotic use was not noted in the ice arm on subsequent postoperative days may have been because the average
AC C
length of use for ice packs was 2.81 days (SD 2.24) which included the day of surgery as day 1. Ice works locally and for a short period of time following its removal. It is logical that we did not see reduced amount of narcotic use in subsequent days when patients were no longer using ice packs. Perhaps if patients had used the ice packs for longer, narcotic use would have been lower in subsequent days. All patients in the cryotherapy arm received ice pack placement for 24 hours. They were told to continue using ice packs per their preference. A longer duration of cryotherapy
10
ACCEPTED MANUSCRIPT
may have a durable effect on decreased narcotic usage, but needs to be studied separately. There is already some evidence for cryotherapy’s ability to reduce narcotic use, particularly in the orthopedic literature.34-38 Our study affirms that cryotherapy can reduce postoperative narcotic
RI PT
use in patients undergoing major abdominal operations.
There was no statistical difference in length of stay between the control and cryotherapy group.
SC
Liver, pancreatic, colon, renal, and pelvic resections were fairly equivalent between groups. Diagnostic exploratory laparotomies due to intraoperative metastasis or non-resectable disease
M AN U
were also equivalent. It is unclear why length of stay did not differ between the two groups. One explanation is that morphine equivalents were not reduced to a clinically significant level between the two groups. Theoretically there should be an effect given the improved pain control and decreased narcotic use. Su et al showed that a cryopneumatic device reduced narcotic use
TE D
two weeks post discharge as well as improved distance of ambulation in patient’s undergoing total knee arthoplasty.31 We did not study early ambulation, time to bowl function, Tordaol use, or use of narcotics following discharge, but these outcomes would be important to review in
EP
subsequent studies. Retrospective review of these variables was attempted but documentation was not consistent among the available records. Ileus was, however, equally documented in both
AC C
the cryotherapy and control group on retrospective review.
The study has a several limitations. Double blinding is impossible due to the nature of ice packs, which allow patients and staff to be readily aware of its presence. Patients were therefore only blinded prior to their operation. The nature of ice packs also prevented the use of a placebo. A placebo room temperature filled pouch was considered during trial design, however, our team
11
ACCEPTED MANUSCRIPT
felt that this would not qualify as a true placebo as patients and providers would know it is at room temperature. Additionally, our study design asked patients to fill out the visual analog pain scale twice a day at regular intervals rather than average their pain over the day. Future studies
RI PT
may also utilize gel packs instead of ice bags to minimize leakage, which was a rare occurrence in our group. We chose not to use gel packs because of the increased cost to the patient.
It is also possible that there may have been a positive compression effect as seen with abdominal
SC
binders, which may have impacted pain relief. A filled ice pack weights approximately 1.5 pounds which is similar to a cough pillow. The compressive effect could be studied in the future
M AN U
by comparing pain control of a cough pillow versus an ice pack. However, there is sound evidence in the literature that cryotherapy decreases cell metabolic demands and reduces inflammation. Anecdotally, ice packs are better tolerated than binders, especially by women who often complain of discomfort along their breasts. In terms of cost, ice packs cost less than
TE D
abdominal binders (less than $2 versus greater than $20). The compressive effects of a binder and an ice pack are also different with the binder distributing pressure with greater strength and over a larger surface area. Use of a binder with an ice pack may have a synergistic effect that
EP
should be studied further.
AC C
Patients in this trial underwent a variety of operations. Future studies on the topic should assess the efficacy of ice packs on a standardized operation to minimize confounders (open pylorus preserving pancreaticoduodenectomy for example). As with all studies, it is possible we did not account for all differences and there may be unconsidered confounders. Finally, it would be interesting to study systemic levels of inflammatory markers among patients provided with postoperative ice packs.
12
ACCEPTED MANUSCRIPT
Conclusion Ice packs are a simple, cost-effective adjuvant to standard postoperative pain management. Although ice pack use does not affect hospital stay in surgical patients, it does significantly
RI PT
reduce postoperative midline incisional pain and narcotic use in patients undergoing major open
AC C
EP
TE D
M AN U
SC
abdominal surgery.
13
ACCEPTED MANUSCRIPT
References 1. Reuben SS, Eckman EF. The effect of initiating a preventive multimodal analgesic regimen on long-term patient outcomes for outpatient anterior cruciate ligament reconstruction surgery.
RI PT
Anesth Analg 2007;105:19-20.
2. Holder KA, Dougherty TB, Porche VH et al. Postoperative pain management. Int Anesthesiol Clin 1998;36:71-86.
SC
3. Pelissier EP. [How can pain of surgery be limited?] Ann Fr Anesth Reanim 1998;17:613-621.
2007;11:5-13.
M AN U
4. Reuben SS. Chronic pain after surgery: what can we do to prevent it. Curr Pain Headache Rep
5. Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology 2000;93:1123-1133.
6. Reuben SS, Buvanendran M. Preventing the development of chronic pain after orthopaedic
TE D
surgery with preventive multimodal analgestic tehniques. J Bone Joint Surg Am 2007;89:13431358.
7. Reuben SS, Eckman EF Charron D. Evaluating the analgesic efficacy of administering
EP
celecoxib as a component of multimodal analgesia for outpatient anterior cruciate ligament reconstruction surgery. Anesth Analg 2007;105:19-20.
AC C
8. Michaloliakou C, Chung F, Sharma S. Preoperative multimodal analgesia facilitates recovery after ambulatory laparoscopic recovery after ambulatory laparoscopic cholecystectomy. Anesth Analg 1996;82:44-51.
9. Schumacher MA, Basabaum AI. Chapter 31. Opiod analgesics and antagonists. In: Katsung B, Master S, Trevor A, eds. Basic and Clinical Pharmacology. 11th ed. San Francisco: McGrawHill 2009.
14
ACCEPTED MANUSCRIPT
10. Wheeler M, Oderda G, Ashburn M, Lipman A. Adverse events associated with postoperative opiod analgesia; a systemic review. J Pain 2002;3:159-180. 11. Faboya A, Uncles D. Post Caesarean delivery pain management: multimodal approach. Int J
RI PT
Obstet Anesth 2007;15:185-186.
12. Mitchinson AR, Kim H, Rosenberg JM, et al. Acute postoperative pain management using massage as an adjuvant therapy: a randomized trial. Arch Surg 2007;142:1158-1167.
SC
13. Raue W, Haase O, Junghans T, et al. 'Fast-track' multimodal rehabilitation program improves outcome after laparoscopic sigmoidectomy: a controlled prospective evaluation. Surg Endosc
M AN U
2004;18:1463-1468.
14. Kwekkeboom KL. Pain management strategies used by patients with breast and gynecologic cancer with postoperative pain. Cancer Nurs 2001;24:378-386.
15. Nalder SF, Weingand K, Kruse RJ. The physiologic basis and clinical applications of
TE D
cryotherapy and thermotherapy for the pain practitioner. Pain Physician 2004;7:395-399. 16. Muldoon J. Skin cooling, pain and chronic wound healing progression. Br J Community Nurs 2006;11:S24-S25.
Nurs 1994;13:21-30.
EP
17. McDowell JH, McFarland EG, Nalli BJ. Use of cryotherapy for orthopaedic patients. Orthop
AC C
18. Hirvonen HE, Mikkelsson MK, Kautiainen H, et al. Effectiveness of different cryotherapies on pain and disease activity in active rheumatoid arthritis. a randomized single blinded controlled trial. Clin Exp Rheumatol 2006;24:295-301. 19. Evans PJ. Cryoanalgesia. The application of low temperatures to nerves to produce anaesthesia or analgesia. Anaesthesia 1981;36:1003-1013.
15
ACCEPTED MANUSCRIPT
20. Swenson C, Swärd L, Karlsson J. Cryotherapy in sports medicine. Scand J Med Sci Sports 1996;6:193-200. 21. Greenstein G. Therapeutic efficacy of cold therapy after intraoral surgical procedures: a
RI PT
literature review. J Peridontol 2007;78:790-800.
22. Hubbard TJ, Denegar CR. Does cryotherapy improve outcomes with soft tissue injury? J Athl Train 2004;39:278-279.
SC
23. Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft tissue injury: a systemic review of randomized controlled trials. Am J Sports Med 2004;32:251-261.
M AN U
24. Ernst E, Fialka V. Ice freezes pain? a review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage 1994;9:56-59.
25. Meeusen R, Lievens P. The use of cryotherapy in sports medicine. Sports Med 1986;3:398414.
TE D
26. Koc M, Tez M, Yoldas O, et al. Cooling for the reduction of postoperative pain: prospective randomized study. Hernia 2006;10:184-186.
27. Kerschan-Schinl K, Uher EM, Zauner-Dungl A, Fialka-Moser V. [Cold and cryotherapy. a
1998;25:73-78.
EP
review of the literature on general principles and practical applications.]. Acta Medica Austriaca
AC C
28. Butterworth JF 4th, Walker FO, Neal JM. Cooling potentiates lidocaine inhibition of median nerve sensory fibers. Anesthesia Analgesia 1990;70:507-511. 29. DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analogue scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg 1998;86:102–106
16
ACCEPTED MANUSCRIPT
30. van der Westhuijzen A, Becker P, Morkel J, Roelse J. A randomized observer blind comparison of bilateral facial ice pack therapy with no ice pack therapy following third molar surgery. Int J Oral Maxillofac Surg 2005;34:281-286
RI PT
31. Su EP, Perna M, Boettner F, et al. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasy recovery. J Bone Join Surg Br 2012; 94: 153-156.
SC
32. Sarifakioglu N, Sarifakioglu E. Evaluating the effects of ice application on the pain felt
Ann Plast Surg 2004; 543-546.
M AN U
during botulinum toxin type-a injections: a prospective, randomized, single-blind controlled trial.
33. Akan M, Misirlioglu A, Yildirim S, et al. Ice application to minimize pain in the splitthickness skin graft donor site. Aesthetic Plast Surg 2003; 305-307. 34. Waterman B, Walker JJ, Swaims C, et al. The efficacy of combined cryotherapy and
TE D
compression compared with cryotherapy alone following anterior cruciate ligament construction. J Knee Surg 2012; 25:155-160.
35. Fang L, Hung CH, Wu SL, et al. The effects of cryotherapy in relieving postarthroscopy
EP
Pain. J Clin Nurs 2012; 21: 636-643.
36. Scheffler NM, Sheitel PL, Lipton MN. Use of cryo/cuff for the control of postoperative pain
AC C
and edema. J Foot Surg 1992; 31: 141-148. 37. Cohn BT, Draeger RI, Jackson DW. The effects of cold therapy in the postoperative management of pain in patients undergoing anterior cruciate ligament reconstruction. Am J Sports Med 1998; 17:344-349. 38. Whitelaw GP, DeMuth KA, Demos HA, et al. The use of cryo/cuff versus ice and elastic wrap in the postoperative care of knee arthroscopy patients. Am J Knee Surg 1995;8:28-30.
17
ACCEPTED MANUSCRIPT
39. Rotenberg BW, Wickens B, Parnes J. intraoperative ice pack application for uvulopalatoplasty pain reduction: a randomized controlled trial. Laryngoscope 2013; 123: 533536.
sustained during childbirth. Cochrane Database Syst Rev. 2012;16.
RI PT
40. East CE, Begg L, Henshall NE, et al. Local cooling for relieving pain from perineal trauma
41. Forouzanfar T, Sabelis A, Ausems S, et al. Effect of ice compression on pain after
SC
mandibular third molar surgery: a single blind, randomized controlled trial. Int J Oral Maxillofac Surg 2008; 824-830.
for lid surgery. Orbit 2006; 107-110.
M AN U
42. Goel S, Chang B, Bhan K, et al. “Cryoanalgesic preparation” before local anesthetic injection
43. East CE, Begg L, Henshall NE, et al. Local cooling for relieving pain from perineal trauma sustained during childbirth (Review). Cochrane Database Syst Rev 2012;9.
TE D
44. Finan MA, Roberts MS, Florica JV, et al. The effects of cold therapy on postoperative pain in
AC C
EP
gynecologic patients: a prospective, randomized study. Am J Obstet Gynecol 1993; 168:542-544.
18
ACCEPTED MANUSCRIPT
Table 1. Preoperative Patient Characteristics
RI PT
p Value 0.160 1.96 0.324 0.609 0.256
AC C
EP
TE D
M AN U
SC
Value Age, mean (SD) Sex, % male BMI, kg/m2, mean (SD) Preoperative narcotic use, n Preoperative pain score, mean (SD)
Randomization Ice Control 62.2 (13.7) 57.0 (12.7) 53.8% 62.1% 25.9 (5.3) 27.2 (4.5) 3 2 0.1 (0.5) 0.7 (1.8)
19
ACCEPTED MANUSCRIPT
Table 2. Operative Characteristics
12.4 (26.6)
RI PT
14.6 (29)
p Value 0.453 0.335 0.982
AC C
EP
TE D
M AN U
SC
Value Incision length, cm, mean (SD) Combined length of additional incisions, mean (SD) 0.25 Marcaine equivalents injected into wound in mL, mean (SD)
Randomization Ice Control 18.7 (7.9) 20.2 (6.2) 0.3 (0.6) 0.3 (0.6)
20
ACCEPTED MANUSCRIPT
Table 3. Postoperative pain management characteristics Randomization, n (%) Ice Control 13 (48.1) 8 (28.6) 7 (25.9) 10 (35.7) 0 (0) 3 (11.1) 4 (14.8) 3 (10.7)
RI PT
p Value 0.171 0.565 0236 0.699
AC C
EP
TE D
M AN U
SC
Value PCA Epidural On Q pump Lidocaine patch
21
ACCEPTED MANUSCRIPT
Table 4. Postoperative Characteristics Randomization Ice Control 6.5 (2.9) 5.7 (3.3) 6 4 3 1 2 2
RI PT
p Value 0.367 0.528 0.193 1.00
AC C
EP
TE D
M AN U
SC
Value Hospital stay, d, mean (SD) Pulmonary complications Wound infection Ileus
22
ACCEPTED MANUSCRIPT
Figure Legends
Figure 2. Flow chart of participants’ progress through the study.
RI PT
Figure 1. Standard icepack placed on a midline incision.
SC
Figure 3. Self-reported pain by time for patients in the cryotherapy and control study arms. Pain was measure using a visual analog scale. Pain measurements were taken preoperatively,
M AN U
perioperatively in the postanesthesia care unit, and twice daily during each postoperative day. Self-reported pain among ice and control patients was significantly different on POD 1 AM (p=0.042), POD 1 PM (p=0.001), and POD 3 PM (p=0.039). *Statistically significant (p < 0.05). Blue bar, cryotherapy; red bar, control.
TE D
Figure 4. Morphine equivalents of narcotic usage. Equivalents were calculated in the postanesthesia care unit (p= 0.117), and then daily in 24 hours (POD1, p=0.008), 48 hours
EP
(POD2, p=0.0164 ), and 72 hours (POD3, p=0.111) hours postoperatively. *Statistically
AC C
significant (p < 0.05). Blue bar, cryotherapy; red bar, control.
23
ACCEPTED MANUSCRIPT
Precis Fifty-five patients undergoing major abdominal operations were randomized to receive cryotherapy (ice packs) vs no cryotherapy to midline incisions. This simple intervention reduced
AC C
EP
TE D
M AN U
SC
RI PT
pain scores on postoperative day 1 and 3 and narcotic use on postoperative day 1.
24
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT