Liposomal bupivacaine versus indwelling interscalene nerve block for postoperative pain control in shoulder arthroplasty: a prospective randomized controlled trial

ARTICLE IN PRESS J Shoulder Elbow Surg (2017) ■■, ■■–■■

www.elsevier.com/locate/ymse

ORIGINAL ARTICLE

Liposomal bupivacaine versus indwelling interscalene nerve block for postoperative pain control in shoulder arthroplasty: a prospective randomized controlled trial Jeffrey T. Abildgaard, MDa, Keith T. Lonergan, MDa, Stefan J. Tolan, MDa, Michael J. Kissenberth, MDa, Richard J. Hawkins, MDa, Richard Washburn III, MDa, Kyle J. Adams, BSb, Catherine D. Long, BSb, E. Carlisle Shealy, BSb, Jay R. Motley, MDc, John M. Tokish, MDa,* a

Steadman Hawkins Clinic of the Carolinas, Greenville Health System, Greenville, SC, USA Hawkins Foundation, Greenville, SC, USA c Department of Anesthesiology, Greenville Health System, Greenville, SC, USA b

Background: Pain management strategies following shoulder arthroplasty vary significantly. Liposomal bupivacaine (LB) is an extended-release delivery of a phospholipid bilayer encapsulating bupivacaine that can result in drug delivery up to 72 hours. Prior studies in lower extremity surgery demonstrated efficacy of LB in comparison to a single-shot peripheral nerve block; however, no study has investigated LB in a total shoulder arthroplasty population. Therefore, this study compared LB vs. an indwelling interscalene nerve block (IINB). Methods: This is a prospective, randomized study of 83 consecutive shoulder arthroplasty patients; 36 patients received LB and a “bridge” of 30 mL of 0.5% bupivacaine, and 47 patients received an IINB. Postoperative visual analog scale pain levels, opiate consumption measured with oral morphine equivalents, length of hospital stay, and postoperative complications were recorded. Continuous variables were compared using an analysis of variance with significance set at P < .05. Results: Visual analog scale pain scores were statistically higher in the LB cohort immediately postoperatively in the postanesthesia care unit (7.25 vs. 1.91; P = .000) as well as for the remainder of postoperative day 0 (4.99 vs. 3.20; P = .005) but not for the remainder of admission. Opiate consumption was significantly higher among the LB cohort in the postanesthesia care unit (31.79 vs. 7.47; P = .000), on postoperative day 0 (32.64 vs. 15.04; P = .000), and for the total hospital admission (189.50 vs. 91.70, P = .000). Complication numbers and length of stay were not statistically different.

Institutional Review Board approval for this project is from Greenville Health System: No. Pro00029618. *Reprint requests: John M. Tokish, MD, Steadman Hawkins Clinic of the Carolinas, Greenville Health System, 200 Patewood Drive, Suite C100, Greenville, SC 29615, USA. E-mail address: [email protected] (J.M. Tokish). 1058-2746/$ - see front matter © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. http://dx.doi.org/10.1016/j.jse.2017.03.012

ARTICLE IN PRESS 2

J.T. Abildgaard et al. Conclusion: Use of an IINB provides superior pain management in the immediate postoperative setting as demonstrated by decreased narcotic medication consumption and lower subjective pain scores. Level of evidence: Level I; Randomized Controlled Trial; Treatment Study © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. Keywords: Shoulder arthroplasty; reverse shoulder arthroplasty; pain management; liposomal bupivacaine; interscalene nerve block; outcomes

Recent literature has demonstrated the critical importance of immediate postoperative pain control after total joint arthroplasty. Patients with poor postoperative pain management in the first 48 hours have approximately a 50% chance of achieving long-term satisfactory pain relief.37 In addition, inadequate pain management has been shown to contribute to an increased incidence of postoperative complications.37 Peripheral nerve blocks have become an increasingly popular method of providing regional anesthesia after orthopedic procedures. Shoulder arthroplasty often uses either a single shot or an indwelling catheter interscalene nerve block (IINB) for procedural anesthesia and postoperative pain management. Interscalene nerve blocks have been shown to decrease narcotic requirements, pain scores, and time to discharge as well as to increase early joint range of motion.18,32 Although effective at decreasing opioid requirements, peripheral nerve blocks expose the patient to an additional procedure with associated complications. Interscalene blocks have been associated with cardiovascular instability (ie, bradycardia and hypotension) in up to 29% of patients operated on in a beach chair position.5,9,10,20,23,31 Neurologic complications, including persistent neurologic pain, dysesthesia down the arm, postoperative paralysis, perineural entrapment of the catheter, vocal cord paralysis, and hemidiaphragmatic paralysis from phrenic nerve palsy, have also been described.1,4,12,22,26,34 Finally, there is a significant cost to regional management of pain, which may be better controlled with an injectable option. Local anesthetics provide additional mediums for pain control at surgical sites and avoid the need for an additional anesthetic procedure. Unfortunately, the half-life of most local anesthetics is brief. Soft tissue infiltration of liposomal bupivacaine (LB) at the surgical site has been reported to extend the active duration of analgesia with local anesthetics up to 72 hours.6 The increased analgesic time with local anesthetics has been shown to provide decreased overall use of opioids for pain management and to decrease pain scores in total hip arthroplasty, total and unicompartmental knee arthroplasty, and forefoot surgery.11,28,33,36 In the setting of total knee arthroplasty, LB has demonstrated equal efficacy to adductor canal or femoral nerve blocks in terms of narcotic requirements, pain scores, length of stay, and cost.21,35,39 Use of LB in the setting of shoulder arthroplasty is a relatively new strategy for pain management, with only one prior randomized controlled trial evaluating its efficacy.25 Therefore,

the purpose of this study was to compare the efficacy of LB and IINB in immediate postoperative pain control as measured by patients’ subjective pain scores and in-hospital opioid medication use. We hypothesized that there would be no difference in pain score levels and opioid medication use throughout admission.

Methods This study is a prospective, randomized controlled trial in a population undergoing both primary anatomic and reverse total shoulder arthroplasty. Patients who were older than 18 years and candidates for a total shoulder arthroplasty with either an anatomic or reverse prosthesis were eligible for enrollment. Study exclusion criteria included pregnancy and patients with hepatic disease. Patients were then randomized to receive either an interscalene nerve block or LB (Exparel, bupivacaine liposomal suspension; Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA). A random number generator was used to establish a randomization list before the start of enrollment. The randomization list was not made available to the surgeons at any point during patient enrollment. All procedures were performed by shoulder fellowship–trained surgeons with significant experience in shoulder arthroplasty. Before study recruitment, 3 patients were recruited to receive the study drug. The purpose of the pilot patients was for the study physicians to standardize their method of drug administration in an effort to minimize variations in drug administration among the investigators and to standardize study protocols. During the surgical procedure, patients who were randomized to receive the study treatment received a 20-mL injection of LB mixed in 40 mL of saline by syringe into the posterior capsule before implantation of the humeral head component. After implantation of the humeral component, the soft tissues surrounding the subscapularis, deltoid, and periosteum of the proximal humerus were also injected for a total of 266 mg delivered, per the manufacturer’s maximum allowed dose. An additional syringe containing 30 mL of 0.5% bupivacaine was injected into the subcutaneous tissues, posterior capsule, and subdeltoid space following the LB injection to provide a bridge between the surgical procedure and the time at which the LB takes effect. Patients randomized to the control group had an interscalene block placed preoperatively by an anesthesiologist with experience in performing ultrasoundguided injections. An indwelling catheter was placed at the time of the interscalene block and left in place postoperatively throughout admission, for approximately 72 hours in total. Nerve block consisted of 0.5% ropivacaine with catheters set to administer 8 mL/ h. During surgery, patients with an indwelling catheter received no local anesthetic injections. Postoperative pain was measured by the nursing staff in accordance with institutional policies. Visual analog scale (VAS) pain levels

ARTICLE IN PRESS Postoperative pain control in shoulder arthroplasty Table I

3

Patient demographics and secondary outcomes

Demographics

IINB

LB

P value

No. of patients TSA RSA Gender Length of stay PACU time Complications Antiemetic medication

46 12 34 14 M/32 F 1.87 1:14 5 13 (28%)

37 19 18 21 M/16 F 1.95 1:23 4 17 (45%)

.798

.662 .121 1.000 .163

TSA, total shoulder arthroplasty; RSA, reverse shoulder arthroplasty; IINB, indwelling catheter interscalene nerve block; LB, liposomal bupivacaine; PACU, postanesthesia care unit.

were recorded in the postanesthesia care unit (PACU) and at all intervals when pain medication was administered. The highest VAS score in the PACU was recorded as a reflection of the worst immediate postoperative pain experienced. Remaining VAS scores once patients left the PACU were averaged for each postoperative day (POD 0, POD 1, and so on). The total number of pain medications per day was recorded for each patient (both narcotic and nonnarcotic), along with the total amount of opiate medications administered intraoperatively, immediately postoperatively in the PACU, and on each postoperative day that the patient was in the hospital. Narcotic pain medications were converted to oral morphine equivalents (OMEs) on the basis of published tables enabling different narcotic medications to be converted to a standardized narcotic quantity.19 Total length of hospital stay measured in days and time spent in the PACU postoperatively were also recorded. Last, the medical record was reviewed postoperatively to evaluate for complications in the postoperative global period of 90 days, along with the number of patients who required antiemetic medications in the hospital. Baseline demographics between groups were examined using a Student t-test and χ2 tests. Continuous variables were compared using analysis of variance, and a χ2 analysis was performed to evaluate complications. An a priori power analysis was conducted, which determined that 80 patients would be necessary for study inclusion; α was set at P ≤ .05 for all analyses. Baseline demographics (Table I) demonstrated significant differences in the control vs. study group for 2 categories: gender (P = .016) and surgical procedure performed (reverse or anatomic shoulder arthroplasty; P = .018); therefore, multivariate regression was performed. Regression confirmed no association between demographic factors and VAS pain scores and opiate requirements.

Results Ninety-six patients were recruited for enrollment in this randomized controlled trial. Overall, 13 patients dropped out of the study, 12 from the LB group and 1 from the IINB cohort. Nine patients had surgery cancelled because of medical issues, financial considerations, or other life circumstance not known to the staff at the time of study enrollment. Two patients underwent revision procedures and were withdrawn. One patient had a change to the surgical procedure intraoperatively, and

Figure 1 Mean subjective pain scores (visual analog scale [VAS]) during hospitalization reflecting lower pain levels during the immediate postoperative period in the indwelling catheter interscalene nerve block (IINB) cohort. LB, liposomal bupivacaine; PACU, postanesthesia care unit; POD, postoperative day.

Figure 2 Mean opiate consumption (oral morphine equivalents) during hospitalization demonstrating lower levels of opiate consumption at all time points for indwelling catheter interscalene nerve block (IINB). LB, liposomal bupivacaine; OR, operating room; PACU, postanesthesia care unit; POD, postoperative day.

the final patient voluntarily withdrew from the study after prior enrollment. This left 46 patients who received the control intervention and 37 who received LB for a total of 83 patients (Table I). The primary outcomes of the study were postoperative VAS pain levels (Fig. 1) and postoperative opioid requirements (Fig. 2). The average highest recorded VAS scores in the PACU were 7.25 (range, 0-10) in the LB group compared with an average of 1.91 (range, 0-10) in the IINB group (P < .0005) (Table II). VAS scores for the remainder of POD 0 stayed higher in the LB group, 4.99 (range, 0-10), than in the IINB cohort, 3.20 (range, 0-8.2) (P = .005). For the remainder of the hospitalization, no differences between VAS scores were noted. On POD 1, VAS scores were 5.21 (range, 0-9.7) for the LB group and 4.99 (range, 0-9.7) (P = .365) for those receiving IINB. Opioid use immediately postoperatively in the PACU was higher in the LB group, 31.79 OMEs (range, 0-90), than among those who received an IINB, 6.26 OMEs (range, 0-40)

ARTICLE IN PRESS 4

J.T. Abildgaard et al. Table II Primary outcome measures of subjective pain scores (VAS) and pain medication consumption, both opiate and nonnarcotic medications IINB VAS PACU POD 0 POD 1 POD 2 Opiate medications (OMEs) OR PACU POD 0 POD 1 POD 2 Total Non-narcotic pain medications PACU POD 0 POD 1 POD 2 Total

LB

P value

1.91 3.20 4.83 3.52

7.25 4.99 5.29 4.09

.000 .005 .365 .402

7.47 6.26 15.04 46.84 19.29 91.7

37.00 31.79 32.64 65.07 31.25 189.6

.000 .000 .000 .092 .070 .000

0.11 0.57 0.98 0.5 2.07

0.54 0.47 0.95 0.54 2.35

.001 .515 .893 .868 .516

VAS, visual analog scale; IINB, indwelling catheter interscalene nerve block; LB, liposomal bupivacaine; OMEs, oral morphine equivalents; OR, operating room; PACU, postanesthesia care unit; POD, postoperative day.

(P < .000). Opiate requirements continued to be higher among the LB cohort for the remainder of POD 0, 32.64 (range, 0-109.5) vs. 15.04 (range, 0-92.5) (P < .000) and on POD 1, 65.07 (range, 0-157.5) vs. 46.84 (range, 0-235) (P = .092). Mean total opiate use throughout hospitalization was more than twice as much among the LB cohort, 189.58 vs. 91.7 (P < .000). In addition, nonopiate pain medications were evaluated for each group per day and throughout admission. Whereas the total mean number of nonopiate pain medications was higher in the PACU for those patients randomized to LB (0.54 vs. 0.11; P = .001), the total amount of nonopiate pain medications during hospitalization was not statistically different in either group, with the IINB group receiving a mean of 2.07 medications vs. 2.35 in the LB cohort (P = .516). Nonopiate pain medications included acetaminophen, intravenous ketorolac, oral ibuprofen, and celecoxib. Seventeen patients (45%) randomized to LB required the use of antiemetic medications as opposed to 13 (28%) with IINB (P = .163). Average length of stay was similar between the 2 groups (Fig. 3), with patients in the LB group staying an average of 1.95 days (range, 1-6) and patients in the IINB group staying 1.87 days (range, 1-4) (P = .662). Time recovering in the PACU was also similar among the 2 groups, 1 hour and 23 minutes vs. 1 hour and 14 minutes, favoring the IINB group (P = .121). Five patients (10.9%) who received an IINB were noted to have complications, which included 2 patients readmitted for pulmonary embolism (1 patient had concurrent

Figure 3 Percentage of patients discharged home per postoperative day (POD). LB, liposomal bupivacaine; IINB, indwelling catheter interscalene nerve block.

pneumonia), 1 patient with readmission for atrial fibrillation in rapid ventricular response on POD 5, 1 patient discharged home with a urinary catheter for urinary retention, and 1 patient with prolonged hospitalization for altered mental status. Four patients (10.8%) had complications in the LB cohort. One patient fell approximately 2 weeks postoperatively and required revision surgery, 1 patient had an upper extremity deep venous thrombosis, 1 patient had a prolonged admission for altered mental status, and 1 patient required naloxone administration for respiratory depression that was noted to resolve after 2 doses. Nausea requiring antiemetic medication was also evaluated postoperatively. Seventeen (45%) of those who had LB required antiemetic medications vs. 13 (28%) among those receiving IINB (P = .163).

Discussion Postoperative pain management for shoulder surgery continues to be a controversial topic. The use of regional anesthesia has been shown to convey several advantages, including the ability to lower consumption of narcotic medications, to decrease baseline and dynamic pain, to allow earlier mobilization, and to shorten time to discharge readiness.2,17 The results of this study indicate that in the immediate postoperative period, regional anesthesia with an IINB provides better pain control than LB. Pain scores and narcotic use assessed immediately after surgery and for the remainder of the operative day were significantly higher among those patients who were randomized to the LB group. Narcotic medication use and subjective pain scores remained higher each hospital day that followed until discharge; however, differences were no longer statistically significant. Several previous studies have shown LB to demonstrate equal or favorable results compared with peripheral nerve blocks. In the setting of anatomic and reverse shoulder arthroplasty, Okoroha et al conducted a prospective randomized study of 57 patients comparing the efficacy of LB with

ARTICLE IN PRESS Postoperative pain control in shoulder arthroplasty that of a single-shot interscalene block.25 Similar to this study, improved pain control was noted in the interscalene block cohort in the early postoperative period. However, narcotic medication use was higher in the interscalene block group, with use being highest in the period coinciding with the block’s wearing off. In this study, the IINB cohort demonstrated lower narcotic consumption on POD 0, on POD 1, and over the entire hospitalization. It is possible the discrepancy between these 2 studies is based on the type of interscalene block used alone. In a comparison of a single-shot interscalene block vs. a patientcontrolled catheter system, Goebel et al previously noted decreased narcotic use during the first 24 hours with an indwelling catheter system.13 For use in total knee arthroplasty, Webb et al evaluated the use of LB in addition to single-shot femoral and sciatic nerve blocks vs. the nerve blocks alone.36 Narcotic use was similar in the first 24 hours; however, the LB group had decreased narcotic consumption from 24 to 72 hours. Yu et al retrospectively compared LB with a single-shot femoral nerve block among 1110 patients in the setting of primary total knee arthroplasty.39 No statistical difference was noted in pain scores between the 2 groups, and fewer narcotics were consumed among the LB group during hospitalization. In addition, the LB cohort was more likely to achieve the functional milestones of ambulating 100 feet and completing stairs before discharge while demonstrating a decreased fall risk during hospitalization. In a retrospective, matched cohort study, Wang et al compared LB with an indwelling adductor canal block for use in total knee arthroplasty.35 They noted lower pain scores with LB in the first 36 hours and decreased opiate medication consumption that approached statistical significance (P = .08). Several confounders existed in this study, however, as different patterns of nonsteroidal antiinflammatory drug use were noted between the 2 groups, with 84.7% of patients in the LB group receiving ketorolac injections as opposed to 18% of the adductor canal block cohort. In contrast to the previously mentioned studies, the results of this study demonstrate that an IINB provides superior pain control for the first 24 hours and decreased narcotic consumption throughout admission. Use of nonopiate medications was similar between the 2 groups, with a statistical difference seen only in the PACU setting as a higher percentage of LB cohort patients received intravenous acetaminophen. Previous authors have noted a period of “uncoverage” that can exist with LB, affecting short-term pain control. Surdam et al noted this in their prospective, randomized study of 80 patients undergoing unicompartmental knee arthroplasty comparing LB with a single-shot femoral nerve block.33 Similar to this study, the femoral nerve block cohort had statistically significant decreased pain levels and lower narcotic consumption on POD 0 compared with the LB group. Average pain scores and total narcotics consumed throughout hospital admission as a whole, however, were no different, leading the authors to conclude that LB was not inferior to a femoral

5 nerve block. In addition, they proposed that a period of LB uncoverage contributed to increased pain scores during the first 24 hours and suggested that future efforts should be directed toward addressing this period of uncoverage. Clinical trials comparing LB with placebo (0.9% saline) in bunionectomy and hemorrhoidectomy, however, suggest that LB does provide reduction in pain during the first 24 hours.15,16 These studies concluded that the LB group had a significant reduction of the area under the curve plotting 0- to 72-hour Numeric Rating Scale pain scores. Analysis of the data demonstrates that the significant reductions occurred during the first 24 hours, and VAS pain scores were similar between the 2 groups during the period of 24 to 72 hours. In an industryfunded study, Apseloff et al concluded that a single subdermal administration of LB exhibited time to onset characteristics similar to traditional bupivacaine HCl with clinically meaningful analgesia within 2 minutes and substantial analgesia after 5 minutes.3 In this study, we attempted to address a period of possible uncoverage by administering an additional injection of 30 mL of 0.5% bupivacaine into the subcutaneous tissues, capsule, and subdeltoid space after final prosthesis implantation. It is possible that the administration location of the 0.5% bupivacaine did not adequately address all areas of possible pain generation and contributed to higher pain scores in the first 24 hours because of analgesic uncoverage. In this study, LB demonstrated equivalent efficacy with regard to hospital length of stay, PACU length of stay, or postoperative complications. Patients were not surveyed about complications directly related to phrenic nerve paralysis, such as subjective breathing difficulty, nor were postoperative oxygen saturation levels recorded as part of the data collection for this study. No patients were noted to have extended hospitalizations secondary to breathing difficulty. Potential complications associated with interscalene blocks have been previously described and can have a potentially profound impact on patient outcomes.1,4,12,22,26,34 Paralysis of the phrenic nerve may be an unacceptable complication in patients with decreased pulmonary capacity, and with an improved preoperative and early postoperative multimodal pain regimen, LB may provide an added role to decrease reliance on interscalene nerve blocks. Narcotic administration alone is known to have numerous side effects, including nausea, vomiting, constipation, dizziness, urinary retention, and respiratory depression.38 Increased levels of narcotics consumed in the LB cohort could very well offset any potential advantages over the potential complications associated with interscalene nerve blocks. In addition, cost was not examined in this study for either cohort. LB has previously been shown to provide a cost savings compared with nerve blocks ranging from $1300 to $1600 per case, and these numbers are comparable to cost calculations at our institution.35 There are several limitations of this study. Although it was randomized and prospective in nature, patients and observers were unable to be blinded, which may have affected pain-reporting behaviors along with provider practice behaviors. Second, although our standard postoperative pain

ARTICLE IN PRESS 6

J.T. Abildgaard et al.

management protocol was used for all patients, some patients may have taken different medications. We attempted to offset for this by evaluating the number of total medications received, along with the number of non-narcotic medications administered. Overall, no significant difference was found in non-narcotic medication administration. In addition, this study failed to evaluate possible psychological or psychosocial factors that may have affected how patients perceived and reported their levels of pain. Previous studies evaluating pain in a postoperative setting have demonstrated a link between perioperative depressive symptoms, anxiety or preoperative distress, and perioperative pain.7,14,24 As an additional limitation, our study also lacked a placebo group, which may have provided another internal control. Comparison to either a placebo, such as 0.9% saline, or 0.5% bupivacaine injection alone could also have provided validation as to the efficacy of LB. Several recent randomized controlled trials have called into question the efficacy of LB compared with other injectable analgesics. Schroer et al, in a comparison of 111 total knee arthroplasty patients randomized to either LB (266 mg) plus 75 mg 0.25% bupivacaine or 150 mg 0.25% bupivacaine alone, found no difference in VAS scores or narcotic consumption during hospitalization.29 In addition, length of stay, discharge disposition, and range of motion on POD 2 and at 3 weeks were all noted to be statistically similar. In another randomized controlled trial in the setting of total knee arthroplasty, Collis et al compared the use of LB to a modified Ranawat suspension containing a combination of ropivacaine, epinephrine, ketorolac, and clonidine.8 They found similar pain scores with no increase in narcotic consumption between the 2 groups at any point during admission as well as statistically similar postoperative range of motion and walking distances. These are not the only randomized controlled trials to call into question the impact of LB as additional recent studies in the setting of total knee arthroplasty have demonstrated no increased efficacy, as has an additional study in the setting of anterior cruciate ligament reconstruction.19,27,30 Given the findings of these studies along with the present study, additional investigation should be conducted to delineate any potential advantages of LB over regional or other forms of local anesthesia in shoulder arthroplasty.

Conclusion This study demonstrates that IINBs provide superior immediate postoperative analgesia along with decreased opiate medication consumption compared with LB and 0.5% bupivacaine in the initial postoperative period. Postoperative length of stay and complications are similar; however, several questions remain about the clinical efficacy of LB in the setting of total shoulder arthroplasty. Future work on multimodal pain management in the setting of shoulder arthroplasty should be undertaken to evaluate an economical and effective pain management strategy.

Disclaimer The authors, their immediate families, and any research foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article.

References 1. Adhikary SD, Armstrong K, Chin KJ. Perineural entrapment of an interscalene stimulating catheter. Anaesth Intensive Care 2012;40:527-30. 2. Aguirre J, Del Moral A, Cobo I, Borgeat A, Blumenthal S. The role of continuous peripheral nerve blocks. Anesthesiol Res Pract 2012;2012:560879. http://dx.doi.org/10.1155/2012/560879 3. Apseloff G, Onel E, Patou G. Time to onset of analgesia following local infiltration of liposome bupivacaine in healthy volunteers: a randomized, single-blind, sequential cohort, crossover study. Int J Clin Pharmacol Ther 2013;51:367-73. http://dx.doi.org/10.5414/CP201775 4. Barutell C, Vidal F, Raich M, Montero A. A neurological complication following interscalene brachial plexus block. Anaesthesia 1980;35: 365-7. 5. Brull R, McCartney CJ, Sawyer RJ, Von Schroeder HP. The indications and applications of interscalene brachial plexus block for surgery about the shoulder. Acute Pain 2004;6:57-77. http://dx.doi.org/10.1016/ j.acpain.2004.04.002 6. Candiotti K. Liposomal bupivacaine: an innovative nonopioid local analgesic for the management of postsurgical pain. Pharmacotherapy 2012;32:(Suppl):19S-26S http://dx.doi.org/10.1002/j.1875-9114 .2012.01183.x 7. Cohen L, Fouladi RT, Katz J. Preoperative coping strategies and distress predict postoperative pain and morphine consumption in women undergoing abdominal gynecologic surgery. J Psychosom Res 2005;58:201-9. http://dx.doi.org/10.1016/j.jpsychores.2004.07.007 8. Collis PN, Hunter AM, Vaughn MD, Carreon LY, Huang J, Malkani AL. Periarticular injection after total knee arthroplasty using liposomal bupivacaine vs a modified Ranawat suspension: a prospective, randomized study. J Arthroplasty 2015;31:633-6. http://dx.doi.org/10 .1016/j.arth.2015.09.025 9. D’Alessio JG, Rosenblum M, Shea KP, Freitas DG. A retrospective comparison of interscalene block and general anesthesia for ambulatory surgery shoulder arthroscopy. Reg Anesth 1995;20:62-8. 10. D’Alessio JG, Weller RS, Rosenblum M. Activation of the Bezold-Jarisch reflex in the sitting position for shoulder arthroscopy using interscalene block. Anesth Analg 1995;80:1158-62. 11. Domb BG, Gupta A, Hammarstedt JE, Stake CE, Sharp K, Redmond JM. The effect of liposomal bupivacaine injection during total hip arthroplasty: a controlled cohort study. BMC Musculoskelet Disord 2014;15:310. http://dx.doi.org/10.1186/1471-2474-15-310 12. Ediale KR, Myung CR, Neuman GG. Prolonged hemidiaphragmatic paralysis following interscalene brachial plexus block. J Clin Anesth 2004;16:573-5. http://dx.doi.org/10.1016/j.jclinane.2004.03.005 13. Goebel S, Stehle J, Schwemmer U, Reppenhagen S, Rath B, Gohlke F. Interscalene brachial plexus block for open-shoulder surgery: a randomized, double-blind, placebo-controlled trial between single-shot anesthesia and patient-controlled catheter system. Arch Orthop Trauma Surg 2010;130:533-40. http://dx.doi.org/10.1007/s00402-009-0985-7 14. Goebel S, Steinert A, Vierheilig C, Faller H. Correlation between depressive symptoms and perioperative pain: a prospective cohort study of patients undergoing orthopedic surgeries. Clin J Pain 2013;29:392-9. http://dx.doi.org/10.1097/AJP.0b013e318262e2c8 15. Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam bupivacaine (extended-release bupivacaine local

ARTICLE IN PRESS Postoperative pain control in shoulder arthroplasty

16.

17.

18.

19.

20.

21.

22.

23.

24. 25.

26.

27.

analgesic) in bunionectomy. Adv Ther 2011;28:776-88. http://dx.doi.org/ 10.1007/s12325-011-0052-y Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extendedrelease liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum 2011;54:1552-9. http://dx.doi.org/10.1097/DCR.0b013e318232d4c1 Ilfeld BM, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, et al. Ambulatory continuous interscalene nerve blocks decrease the time to discharge readiness after total shoulder arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology 2006;105:999-1007. Ilfeld BM, Wright TW, Enneking FK, Morey TE. Joint range of motion after total shoulder arthroplasty with and without a continuous interscalene nerve block: a retrospective, case-control study. Reg Anesth Pain Med 2005;30:429-33. http://dx.doi.org/10.1016/j.rapm.2005.06.003 Jain RK, Porat MD, Klingenstein GG, Reid JJ, Post RE, Schoifet SD. The AAHKS Clinical Research Award: Liposomal bupivacaine and periarticular injection are not superior to single-shot intra-articular injection for pain control in total knee arthroplasty. J Arthroplasty 2016;31(Suppl):22-5. http://dx.doi.org/10.1016/j.arth.2016.03.036 Kahn RL, Hargett MJ. Beta-adrenergic blockers and vasovagal episodes during shoulder surgery in the sitting position under interscalene block. Anesth Analg 1999;88:378-81. Kenes MT, Leonard MC, Bauer SR, Wyman MJ. Liposomal bupivacaine versus continuous infusion bupivacaine via an elastomeric pump for the treatment of postoperative pain. Am J Health Syst Pharm 2015;72(Suppl 3):S127-32. http://dx.doi.org/10.2146/ajhp150168 Lenters TR, Davies J, Matsen FA. The types and severity of complications associated with interscalene brachial plexus block anesthesia: local and national evidence. J Shoulder Elbow Surg 2007;16:379-87. http://dx.doi.org/10.1016/j.jse.2006.10.007 Liguori GA, Kahn RL, Gordon J, Gordon MA, Urban MK. The use of metoprolol and glycopyrrolate to prevent hypotensive/bradycardic events during shoulder arthroscopy in the sitting position under interscalene block. Anesth Analg 1998;87:1320-5. Loeser JD, Melzack R. Pain: an overview. Lancet 1999;353:1607-9. Okoroha KR, Lynch JR, Keller RA, Korona J, Amato C, Rill B, et al. Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: a prospective randomized trial. J Shoulder Elbow Surg 2016;25:1742-8. http://dx.doi.org/10.1016/j.jse.2016.05.007 Plit ML, Chhajed PN, Macdonald P, Cole IE, Harrison GA. Bilateral vocal cord palsy following interscalene brachial plexus nerve block. Anaesth Intensive Care 2002;30:499-501. Premkumar A, Samady H, Slone H, Hash R, Karas S, Xerogeanes J. Liposomal bupivacaine for pain control after anterior cruciate ligament reconstruction: a prospective, double-blinded, randomized, positivecontrolled trial. Am J Sports Med 2016;44:1680-6. http://dx.doi.org/10 .1177/0363546516640772

7 28. Robbins J, Green CL, Parekh SG. Liposomal bupivacaine in forefoot surgery. Foot Ankle Int 2015;36:503-7. http://dx.doi.org/10.1177/ 1071100714568664 29. Schroer WC, Diesfeld PG, LeMarr AR, Morton DJ, Reedy ME. Does extended-release liposomal bupivacaine better control pain than bupivacaine after total knee arthroplasty (TKA)? A prospective, randomized clinical trial. J Arthroplasty 2015;30:64-7. http://dx .doi.org/10.1016/j.arth.2015.01.059 30. Schwarzkopf R, Drexler M, Ma MW, Schultz VM, Le KT, Rutenberg TF, et al. Is there a benefit for liposomal bupivacaine compared to a traditional periarticular injection in total knee arthroplasty patients with a history of chronic opioid use? J Arthroplasty 2016;31:1702-5. http://dx.doi.org/10.1016/j.arth.2016.01.037 31. Sia S, Sarro F, Lepri A, Bartoli M. The effect of exogenous epinephrine on the incidence of hypotensive/bradycardic events during shoulder surgery in the sitting position during interscalene block. Anesth Analg 2003;97:583-8. http://dx.doi.org/10.1213/01.ANE.0000070232.06352 .48. 32. Stundner O, Rasul R, Chiu YL, Sun X, Mazumdar M, Brummett CM, et al. Peripheral nerve blocks in shoulder arthroplasty: how do they influence complications and length of stay? Clin Orthop Relat Res 2014;472:1482-8. http://dx.doi.org/10.1007/s11999-013-3356-1 33. Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of Exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty 2015;30:325-9. http://dx.doi .org/10.1016/j.arth.2014.09.004 34. Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg 1991;72:498503. 35. Wang Y, Klein MS, Mathis S, Fahim G. Adductor canal block with bupivacaine liposome versus ropivacaine pain ball for pain control in total knee arthroplasty: a retrospective cohort study. Ann Pharmacother 2016;50:194-202. http://dx.doi.org/10.1177/1060028015626161 36. Webb BT, Spears JR, Smith LS, Malkani AL. Periarticular injection of liposomal bupivacaine in total knee arthroplasty. Arthroplasty Today 2015;1:117-20. http://dx.doi.org/10.1016/j.artd.2015.09.001 37. Wells N, Pasero C, McCaffery M. Improving the quality of care through pain assessment and management. In: Hughes RG, editor. Patient safety and quality: an evidence-based handbook for nurses, vol. 1. Rockville, MD: Agency for Healthcare Research and Quality; 2004. Chapter 17. 38. Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain 2002;3:159-80. 39. Yu S, Szulc A, Walton S, Bosco J, Iorio R. Pain control and functional milestones in total knee arthroplasty: liposomal bupivacaine versus femoral nerve block. Clin Orthop Relat Res 2017;475:110-7. http://dx.doi.org/10.1007/s11999-016-4740-4