- Email: [email protected]
Postoperative pain relief following laparoscopic tubal sterilization with silastic bands
Postoperative Pain Relief Following Laparoscopic Tubal Sterilization With Silastic Bands AUDREY L. TOOL, MD, DOROTHY N. KAMMERER-DOAK, MD, CUONG M. NGUYEN, MD, MARY 0. COUSIN, AND MARGARET
Objective: To evaluate postoperative pain relief of intramuscular ketorolac, topical bupivacaine, and placebo in patients undergoing laparoscopic tubal sterilization with silastic bands. Methods: One hundred five women undergoing laparoscopic tubal sterilization with silastic bands were randomized to one of three groups: one received intramuscular ketorolac and topical placebo applied to the fallopian tubes, the second received intramuscular placebo and topical bupivacaine, and the third received intramuscular placebo and topical placebo. Surgical procedures, anesthesia, and recovery were conducted with standardized protocols. Postoperative pain perception was graded using the modified McGill pain intensity scale at 30 minutes postoperatively, at discharge from the recovery room, and the next morning by telephone interview. Other measured variables included postoperative vomiting, additional analgesia requirement, and length of time spent in the recovery room. Results: Only topical bupivacaine was found to decrease postoperative pain scores significantly over those with placebo, at 30 minutes postoperatively (median score 2 compared with 4, P = .002) and at discharge from the recovery room (median score 2 compared with 3, P = .03). There was no significant decrease in pain scores with intramuscular ketorolac compared with placebo. No differences in pain scores were found between the three groups at the next morning phone call. There were no significant differences between the three groups with respect to requirements for supplemental pain medications in the recovery room, incidence of postoperative vomiting, or length of time spent in the recovery room. Conclusion: Topical bupivacaine decreases postoperative pain scores significantly compared with placebo in women
From
the Departments @Obstetrics and Gynecology and Anesthesiof Ne-UJ Mexico Health Sciences Centw, Albuquerque, New Mexico. We thank Dr. CIiford Qua//s for his assistance with the statistical analysis. ology,
University
VOL.90,NO.5,NOVEMBER1997
CHARSLEY,
MD
undergoing laparoscopic tubal sterilization with bands. (Obstet Gynecol 1997;90:731-4. 0 1997 American College of Obstetricians and Gynecologists.)
silastic by The
Since the first report by Yoon et al’ in 1974, the silastic band has been used increasingly for laparoscopic tubal sterilization.* In experienced hands, it offers distinct advantages over the traditional electrocautery method. Silastic bands have been shown to be quicker and easier to apply, safer to use, and have an equivalent, or lower failure rate, when compared with electrocautery.3-6 One disadvantage of silastic bands co’mpared with electrocautery is increased immediate postoperative pain.7 There are several theories regarding the etiology of increased pain with silastic bands. One proposes that prostaglandin production secondary to tubal trauma and ischemia act locally to produce painful uterine contractions similar to dysmenorrhea.8*9 This type of pain should respond to a prostaglandin synthesis inhibitor such as a nonsteroidal anti-inflammatory drug. Another theory of postoperative pain with silastic bands involves ischemia and necrosis of the ligated portion of the tube without destruction of adjacent nerve fibers.” This type of pain should respond to a local anesthetic block. Studies’,“-‘” addressing these issues demonstrate superior relief of pain with local anesthetic block over placebo, but are not consistent when comparing nonsteroidal anti-inflammatory drugs with placebo. The objective of our study was to compare postoperative pain relief of an intramuscular nonsteroidal antiinflammatory drug and a topical local anesthetic against placebo in patients undergoing laparoscopic tubal sterilization with silastic bands.
0029-7844/97/$17.00 PI1 50029-7844(97)00434-l
731
Materials and Methods This study protocol was approved by the Human Research Review Committee at the University of New Mexico Health Sciences Center, Albuquerque, New Mexico. Patients presenting to the University Center for Women’s Health gynecology clinic requesting laparoscopic tubal sterilization were asked to participate. Exclusion criteria included 1) history of hypersensitivity to local anesthesia, nonsteroidal anti-inflammatory drugs, acetaminophen, or codeine, 2) cardiac disease, 3) renal disease, 4) coagulation disorder, 5) peptic ulcer disease, 6) requirement for additional surgical procedures at the time of tubal sterilization, and 7) abdominal or pelvic disease precluding the application of the silastic band. Informed consent was obtained from each patient at the time of her preoperative evaluation. Patients were assigned by the research pharmacist with a computer-generated random table of numbers to one of three study groups. The first group of women received 60 mg of ketorolac intramuscularly after intubation and 5 mL of normal saline dripped over each fallopian tube immediately before application of the silastic band. The second group received 2 mL of normal saline injected intramuscularly and 5 mL of 0.5% bupivacaine dripped over each tube just before silastic band application. The third group were controls who received 2 mL of normal saline injected intramuscularly and 5 mL of normal saline topically. Only the research pharmacist knew what drugs were given, because all syringes and vials containing bupivacaine, ketorolac, or normal saline were labelled “study drug.” The patient, anesthesiologist, surgeons, operating room personnel, research nurse, and recovery room personnel were blinded to the type of medication given. Women were excluded from the analysis if more than one silastic band was applied to each tube, or if concurrent surgical procedures were performed. A standardized protocol was used for the induction and maintenance of general anesthesia during surgery. The laparoscopic tubal sterilization procedure was carried out in the usual manner with two trocar sites. The bupivacaine or normal saline was applied to the fallopian tube by injection through a port on the silastic band applicator or by using an 18-gauge 3.5-inch spinal needle introduced through a separate midline puncture site approximately 2 cm superior to the suprapubic trocar site. The solution was dripped over each fallopian tube and the silastic bands were then #applied in the usual manner. In the recovery room, supplemental morphine sulfate, meperidine, and acetaminophen with codeine were given as needed for pain. The conversion factor used to calculate mean milligrams of intravenous sup-
732
Tool et al
Postoperative Pain Re&f
Table
1. Demographic
Information
Ketorolac (n = 30)
Age &avidity Paritv Weight (lb) Height (ft) Data are presented
29.3 3.7 2.7 162.8 5.3
k t? t +
6.4 1.9 1.1 35.0 0.2
Bupivacaine (n = 31) 28.9 3.0 2.3 163.6 5.3
as mean -t standard
2 i 2 2 f
6.0 1.7 0.9 34.6 0.2
Placebo (n = 33) 30.0 :3.6 2.6 157.4 5.3
-___
+ f ? + +-
6.4 1.9 1.4 37.7 0.17
deviation.
plemental pain medication was (mg mor]phine/lO) + (mg meperidine/50) X 10. Supplemental droperidol and ondansetron were given for nausea and vomiting. The modified McGill pain intensity scale,14 ranging from 0 to 5, was used for patients’ self-assessment of postoperative pain (0 = no pain, 1 = mild pain, 2 = discomforting, 3 = distressing, 4 = horrible, and 5 = excruciating pain). Pain scores were assessed at 30 minutes postoperatively, at discharge from the recovery room, and the following day. Patients were discharged home from the recovery room with a prescription for 10 acetaminophen with codeine tablets. A phone call the following day by the clinical research nurse was used to elicit patients’ pain perception at 24 hours postoperatively and the total amount of outpatient pain medication used. A preliminary power analysis demonstrated that 35 patients per group would be required for power of SO%, cy = .05, variance of 1.5, and a delta u value of 1 on the McGill pain scale using the Wilcoxon test. Nonparametric comparison between the three groups was performed using Kruskal-Wallis test. Post hoc pairwise comparisons between groups were performed by Wilcoxon rank sum test. Binary data (ie, Incidence of vomiting) were evaluated with Fisher exact test and continuous variables (ie, ages) with Student f test.
Results One hundred five of 176 eligible women were enrolled in the study from September 1994 through October 1996. Eleven were excluded subsequently for protocol violations (eg, concurrent surgical procedures performed, failure to give study drug, malfunction of applicator requiring sterilization by a different route, etc). Data were incomplete on 18 patients because they could not be contacted by phone the day after surgery, but the data available on these patients were included in the analysis. Ultimately, there were 30 patients in the ketorolac group, 31 patients in the bupivacaine group, and 33 patients in the placebo group. Demographic information is given in Table 1. Using the modified McGill pain intensity scale, the
Obstetrics b Gynecology
Table
2. Postoperative
30 min Discharge 24 h
Pain
a*
Ketorolac pain score
24 24 21
3 (O-5) 2 (O-4) 2 (O-3)
Table
Perception n*
Bupivacaine pain score
n*
Placebo pain score
27 29 27
2+ (O-41 2’(0-41 2 (0 -5)
32 30 28
4 (O-5) 3 (O-5) 2 (O-4)
Data are presented as median (full range). * Number of patients used in analysis. ’ P = ,002 compared with placebo. * P = .03 compared with placebo.
Discussion
Table
significantly decreased postoperative topical bupivacaine over those with
3. Supplemental
Pain
Data are presented as mean ? standard * Number of patients used for analysis.
90, NO.
5, NOVEMBER
30 min Discharge 24 h
2/24 (8%) 5/24 (21%) 4/21 (19%)
Vomiting Bupivacaine
Placebo
l/29 (3%) 5/29 (17%) 3/27 (11%)
l/32 (3%) 3/30 (10%) 3/28 (11%)
P > .05.
as n (%).
placebo, suggesting that the etiology of increased postoperative pain with silastic band sterilization may be ischemia and necrosis of the ligated portion of the tube without destruction of adjacent nerve fibers. Intramuscular ketorolac demonstrated a trend toward improved postoperative pain scores, but the difference was not significant. This finding does not support the theory of prostaglandin production secondary to tubal trauma as an etiology for postoperative pain following tubal sterilization with silastic bands. However, it is possible that ketorolac may have shown a significant improvement in pain scores if data were available for 35 patients per group, as required by our preliminary power analysis. There is concern by some that use of ketorolac may lead to gastrointestinal upset postoperatively. Our findings suggest that this may be the case, as there was a trend toward increased incidence of vomiting postoperatively in the ketorolac grouI when compared with the bupivacaine or placebo groups at all three time periods, although not statistically significant in our data analysis. Ketorolac is significantly more costly than bupivacaine: at our pharmacy in December 1996, the cost of 60 mg of intramuscular ketorolac was $17.65 compared with $6.15 for 10 mL of topical 0.5% bupivacaine. That the significant improvement in postoperative pain scores in the bupivacaine group did not translate into decreased supplemental pain medication requirements or shorter recovery times may be secondary to the reluctance of the recovery room personnel to change their routine recovery protocols despite varying needs of the patients. Given the relative low cost and ease of administration, postoperative comfort alone should be sufficient justification for using topical bupivacaine routinely in patients undergoing laparoscopic tubal sterilization with silastic bands.
Medication
Recovery room Intravenous morphine/meperidine (mg) Oral acetaminophen, codiene (tablets) Home Oral acetaminophen, codiene (tablets)
VOL.
of Postoperative Ketorolac
Data are presented
pain scores at 30 minutes postoperatively and at discharge from the recovery room were significantly lower for the bupivacaine group than placebo (Table 2). There were no significant differences in postoperative pain scores between the ketorolac and placebo groups or between the ketorolac or bupivacaine groups at any time (Table 2). Postoperative supplemental pain medications, both recovery room and oral pain medication following discharge, did not differ significantly between the three groups despite the fact that the bupivacaine group had lower pain scores (Table 3). There was a trend toward increased postoperative vomiting in the ketorolac group at 30 minutes postoperatively, at discharge from the recovery room, and at 24 hours postoperatively. However, this was not statistically significant (Table 4). The length of time for laparoscopic tubal sterilizations, usually performed by the first year resident, did not differ significantly among the three groups. The mean (standard deviation [SD]) surgical time was 65 (39) minutes for the ketorolac subjects, 60 (19) minutes for the bupivacaine women, and 56 (11) minutes for those receiving placebo. Recovery time (length of time from admission to the recovery room until discharge home) was not significantly different between the three groups, with a mean (SD) recovery time of 70 (28) minutes for the ketorolac group, 62 (16) minutes for the bupivacaine group, and 65 (16) minutes for the placebo group.
Our study found pain scores with
4. Incidence
1997
n*
Ketorolac
n*
30 30
6.27 5 4.89 (O-19) 0.36 + 0.49 (O-11
31 31
4.19 2 2.93 (O-10)
27
21 deviation
Bupivacaine
n*
Placebo
4.11 i- 3.51 (O-151 0.23 2 0.43 (O-l)
33 33
5.33 + 4.40 (O-15) 0.42 + 0.50 (O-1)
3.15 2 2.09 (O-8)
28
3.07 k 2.29 (O-81
Tool et al
Postoperative
(range).
Pain
Re2ieJ
733
R$erences 1. Yoon
IB, Wheeless
CR,
King
TM.
A preliminary
report
on a new
laparoscopic sterilization approach: The silicone rubber band technique. Am J Obstet Gynecol 1974;120:132-6. 2. Peterson HB, Hulka J, Phillips JM, Surrey MW. Laparoscopic sterilization: American Association of Gynecologic Laparoscopists 1991 membership survey. J Reprod Med 1993;38:574-6. 3. Ziegler JS, Schneider GT, Caire AA. A comparison ring and laparoscopic tubal cauterization. J Reprod
237-8. 4. Yoon IB, King falope
Parmley TH. procedure.
CJ, Daily HI, Marko MW, sterilization: Experience
A two year experience Am J Obstet Gynecol Richardson DC. with a silastic
LP. Incidence of pain among sterilization by electrocoagulation,
Non electrical band. Obstet
sterilization.
734
Tool
KT, Tomasi tube. Fertil W. Post-operative
Scott
et al
Med
pain
TB, Lippes J. Prostaglandins in the Steril 1974;25:250-5. analgesia following laparoscopic
J 1979;24:220.
Postoperative Pain ReliqF
Jadad AR. Reduction with local bupivacaine: trial. Br J Obstet Gynaecol BL. Intramuscular laparoscopic
13. Van Ee R, Hemrika DJ, DeBlok ketoprofen and mesosalpinx after laparoscopic sterilization. 14. Melzack Ii. The McGill pain methods.
Pain
ketorolac sterilisation.
of pain after A randomised, l994;101:443-6. for postoperative Anaesth lntensive
S, Vanderlinden C, Lip H. Effects of infiltration on postoperative pain Obstet Gynecol 1996;88:568-72. questionnaire: Major properties and
1975;1:277-99.
Address
reprint
requests
to:
Dorothy Kammerer-Doak,
MD and Gynecology University qf New Mexico Hospital 2211 Lomas NE Albuquerque, NM 87131 Department
4 Obstetrics
women undergoing the spring-loaded
clip, and the tubal ring. Am J Obstet Gynecol 1979;135:397-407. 8. Brodie BL, Casper RF. Prostaglandins mediate postoperative in falope ring sterilization. Am J Obstet Gynecol 1985;151:175-7. 9. Ogra SS, Kirton human fallopian 10. Leggat IT, Barr
JM,
with the 1977;127:
Gynecol 1976;48:494-6. 6. Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tyler LR, Trussell J. The risk of pregnancy after tubal sterilization: Findings from the U.S. collaborative review of sterilization. Am J Obstet Gynecol 1996;174:1161-70. 7. Chi IC, Cole laparoscopic
12. Shapiro MH, Duffy analgesia following Care 1994;22:22-4.
scoring
TM, sterilization
ring
109-12. 5. Levinson laparoscopic
of the falope Med 1978;20:
11. Wheatley SA, Millar laparoscopic sterilisation parallel, double-blind
Received April 23, 1997. Received in revised form Accepted July 18, 1997.
Copyright Gynecologists.
0
1997
by
Published
The
]uly 7, 2997.
American
by Elsevier
College Science
of Obstetricians
and
Inc.
Obstetrics & Gynecology
Objective: To evaluate postoperative pain relief of intramuscular ketorolac, topical bupivacaine, and placebo in patients undergoing laparoscopic tubal sterilization with silastic bands. Methods: One hundred five women undergoing laparoscopic tubal sterilization with silastic bands were randomized to one of three groups: one received intramuscular ketorolac and topical placebo applied to the fallopian tubes, the second received intramuscular placebo and topical bupivacaine, and the third received intramuscular placebo and topical placebo. Surgical procedures, anesthesia, and recovery were conducted with standardized protocols. Postoperative pain perception was graded using the modified McGill pain intensity scale at 30 minutes postoperatively, at discharge from the recovery room, and the next morning by telephone interview. Other measured variables included postoperative vomiting, additional analgesia requirement, and length of time spent in the recovery room. Results: Only topical bupivacaine was found to decrease postoperative pain scores significantly over those with placebo, at 30 minutes postoperatively (median score 2 compared with 4, P = .002) and at discharge from the recovery room (median score 2 compared with 3, P = .03). There was no significant decrease in pain scores with intramuscular ketorolac compared with placebo. No differences in pain scores were found between the three groups at the next morning phone call. There were no significant differences between the three groups with respect to requirements for supplemental pain medications in the recovery room, incidence of postoperative vomiting, or length of time spent in the recovery room. Conclusion: Topical bupivacaine decreases postoperative pain scores significantly compared with placebo in women
From
the Departments @Obstetrics and Gynecology and Anesthesiof Ne-UJ Mexico Health Sciences Centw, Albuquerque, New Mexico. We thank Dr. CIiford Qua//s for his assistance with the statistical analysis. ology,
University
VOL.90,NO.5,NOVEMBER1997
CHARSLEY,
MD
undergoing laparoscopic tubal sterilization with bands. (Obstet Gynecol 1997;90:731-4. 0 1997 American College of Obstetricians and Gynecologists.)
silastic by The
Since the first report by Yoon et al’ in 1974, the silastic band has been used increasingly for laparoscopic tubal sterilization.* In experienced hands, it offers distinct advantages over the traditional electrocautery method. Silastic bands have been shown to be quicker and easier to apply, safer to use, and have an equivalent, or lower failure rate, when compared with electrocautery.3-6 One disadvantage of silastic bands co’mpared with electrocautery is increased immediate postoperative pain.7 There are several theories regarding the etiology of increased pain with silastic bands. One proposes that prostaglandin production secondary to tubal trauma and ischemia act locally to produce painful uterine contractions similar to dysmenorrhea.8*9 This type of pain should respond to a prostaglandin synthesis inhibitor such as a nonsteroidal anti-inflammatory drug. Another theory of postoperative pain with silastic bands involves ischemia and necrosis of the ligated portion of the tube without destruction of adjacent nerve fibers.” This type of pain should respond to a local anesthetic block. Studies’,“-‘” addressing these issues demonstrate superior relief of pain with local anesthetic block over placebo, but are not consistent when comparing nonsteroidal anti-inflammatory drugs with placebo. The objective of our study was to compare postoperative pain relief of an intramuscular nonsteroidal antiinflammatory drug and a topical local anesthetic against placebo in patients undergoing laparoscopic tubal sterilization with silastic bands.
0029-7844/97/$17.00 PI1 50029-7844(97)00434-l
731
Materials and Methods This study protocol was approved by the Human Research Review Committee at the University of New Mexico Health Sciences Center, Albuquerque, New Mexico. Patients presenting to the University Center for Women’s Health gynecology clinic requesting laparoscopic tubal sterilization were asked to participate. Exclusion criteria included 1) history of hypersensitivity to local anesthesia, nonsteroidal anti-inflammatory drugs, acetaminophen, or codeine, 2) cardiac disease, 3) renal disease, 4) coagulation disorder, 5) peptic ulcer disease, 6) requirement for additional surgical procedures at the time of tubal sterilization, and 7) abdominal or pelvic disease precluding the application of the silastic band. Informed consent was obtained from each patient at the time of her preoperative evaluation. Patients were assigned by the research pharmacist with a computer-generated random table of numbers to one of three study groups. The first group of women received 60 mg of ketorolac intramuscularly after intubation and 5 mL of normal saline dripped over each fallopian tube immediately before application of the silastic band. The second group received 2 mL of normal saline injected intramuscularly and 5 mL of 0.5% bupivacaine dripped over each tube just before silastic band application. The third group were controls who received 2 mL of normal saline injected intramuscularly and 5 mL of normal saline topically. Only the research pharmacist knew what drugs were given, because all syringes and vials containing bupivacaine, ketorolac, or normal saline were labelled “study drug.” The patient, anesthesiologist, surgeons, operating room personnel, research nurse, and recovery room personnel were blinded to the type of medication given. Women were excluded from the analysis if more than one silastic band was applied to each tube, or if concurrent surgical procedures were performed. A standardized protocol was used for the induction and maintenance of general anesthesia during surgery. The laparoscopic tubal sterilization procedure was carried out in the usual manner with two trocar sites. The bupivacaine or normal saline was applied to the fallopian tube by injection through a port on the silastic band applicator or by using an 18-gauge 3.5-inch spinal needle introduced through a separate midline puncture site approximately 2 cm superior to the suprapubic trocar site. The solution was dripped over each fallopian tube and the silastic bands were then #applied in the usual manner. In the recovery room, supplemental morphine sulfate, meperidine, and acetaminophen with codeine were given as needed for pain. The conversion factor used to calculate mean milligrams of intravenous sup-
732
Tool et al
Postoperative Pain Re&f
Table
1. Demographic
Information
Ketorolac (n = 30)
Age &avidity Paritv Weight (lb) Height (ft) Data are presented
29.3 3.7 2.7 162.8 5.3
k t? t +
6.4 1.9 1.1 35.0 0.2
Bupivacaine (n = 31) 28.9 3.0 2.3 163.6 5.3
as mean -t standard
2 i 2 2 f
6.0 1.7 0.9 34.6 0.2
Placebo (n = 33) 30.0 :3.6 2.6 157.4 5.3
-___
+ f ? + +-
6.4 1.9 1.4 37.7 0.17
deviation.
plemental pain medication was (mg mor]phine/lO) + (mg meperidine/50) X 10. Supplemental droperidol and ondansetron were given for nausea and vomiting. The modified McGill pain intensity scale,14 ranging from 0 to 5, was used for patients’ self-assessment of postoperative pain (0 = no pain, 1 = mild pain, 2 = discomforting, 3 = distressing, 4 = horrible, and 5 = excruciating pain). Pain scores were assessed at 30 minutes postoperatively, at discharge from the recovery room, and the following day. Patients were discharged home from the recovery room with a prescription for 10 acetaminophen with codeine tablets. A phone call the following day by the clinical research nurse was used to elicit patients’ pain perception at 24 hours postoperatively and the total amount of outpatient pain medication used. A preliminary power analysis demonstrated that 35 patients per group would be required for power of SO%, cy = .05, variance of 1.5, and a delta u value of 1 on the McGill pain scale using the Wilcoxon test. Nonparametric comparison between the three groups was performed using Kruskal-Wallis test. Post hoc pairwise comparisons between groups were performed by Wilcoxon rank sum test. Binary data (ie, Incidence of vomiting) were evaluated with Fisher exact test and continuous variables (ie, ages) with Student f test.
Results One hundred five of 176 eligible women were enrolled in the study from September 1994 through October 1996. Eleven were excluded subsequently for protocol violations (eg, concurrent surgical procedures performed, failure to give study drug, malfunction of applicator requiring sterilization by a different route, etc). Data were incomplete on 18 patients because they could not be contacted by phone the day after surgery, but the data available on these patients were included in the analysis. Ultimately, there were 30 patients in the ketorolac group, 31 patients in the bupivacaine group, and 33 patients in the placebo group. Demographic information is given in Table 1. Using the modified McGill pain intensity scale, the
Obstetrics b Gynecology
Table
2. Postoperative
30 min Discharge 24 h
Pain
a*
Ketorolac pain score
24 24 21
3 (O-5) 2 (O-4) 2 (O-3)
Table
Perception n*
Bupivacaine pain score
n*
Placebo pain score
27 29 27
2+ (O-41 2’(0-41 2 (0 -5)
32 30 28
4 (O-5) 3 (O-5) 2 (O-4)
Data are presented as median (full range). * Number of patients used in analysis. ’ P = ,002 compared with placebo. * P = .03 compared with placebo.
Discussion
Table
significantly decreased postoperative topical bupivacaine over those with
3. Supplemental
Pain
Data are presented as mean ? standard * Number of patients used for analysis.
90, NO.
5, NOVEMBER
30 min Discharge 24 h
2/24 (8%) 5/24 (21%) 4/21 (19%)
Vomiting Bupivacaine
Placebo
l/29 (3%) 5/29 (17%) 3/27 (11%)
l/32 (3%) 3/30 (10%) 3/28 (11%)
P > .05.
as n (%).
placebo, suggesting that the etiology of increased postoperative pain with silastic band sterilization may be ischemia and necrosis of the ligated portion of the tube without destruction of adjacent nerve fibers. Intramuscular ketorolac demonstrated a trend toward improved postoperative pain scores, but the difference was not significant. This finding does not support the theory of prostaglandin production secondary to tubal trauma as an etiology for postoperative pain following tubal sterilization with silastic bands. However, it is possible that ketorolac may have shown a significant improvement in pain scores if data were available for 35 patients per group, as required by our preliminary power analysis. There is concern by some that use of ketorolac may lead to gastrointestinal upset postoperatively. Our findings suggest that this may be the case, as there was a trend toward increased incidence of vomiting postoperatively in the ketorolac grouI when compared with the bupivacaine or placebo groups at all three time periods, although not statistically significant in our data analysis. Ketorolac is significantly more costly than bupivacaine: at our pharmacy in December 1996, the cost of 60 mg of intramuscular ketorolac was $17.65 compared with $6.15 for 10 mL of topical 0.5% bupivacaine. That the significant improvement in postoperative pain scores in the bupivacaine group did not translate into decreased supplemental pain medication requirements or shorter recovery times may be secondary to the reluctance of the recovery room personnel to change their routine recovery protocols despite varying needs of the patients. Given the relative low cost and ease of administration, postoperative comfort alone should be sufficient justification for using topical bupivacaine routinely in patients undergoing laparoscopic tubal sterilization with silastic bands.
Medication
Recovery room Intravenous morphine/meperidine (mg) Oral acetaminophen, codiene (tablets) Home Oral acetaminophen, codiene (tablets)
VOL.
of Postoperative Ketorolac
Data are presented
pain scores at 30 minutes postoperatively and at discharge from the recovery room were significantly lower for the bupivacaine group than placebo (Table 2). There were no significant differences in postoperative pain scores between the ketorolac and placebo groups or between the ketorolac or bupivacaine groups at any time (Table 2). Postoperative supplemental pain medications, both recovery room and oral pain medication following discharge, did not differ significantly between the three groups despite the fact that the bupivacaine group had lower pain scores (Table 3). There was a trend toward increased postoperative vomiting in the ketorolac group at 30 minutes postoperatively, at discharge from the recovery room, and at 24 hours postoperatively. However, this was not statistically significant (Table 4). The length of time for laparoscopic tubal sterilizations, usually performed by the first year resident, did not differ significantly among the three groups. The mean (standard deviation [SD]) surgical time was 65 (39) minutes for the ketorolac subjects, 60 (19) minutes for the bupivacaine women, and 56 (11) minutes for those receiving placebo. Recovery time (length of time from admission to the recovery room until discharge home) was not significantly different between the three groups, with a mean (SD) recovery time of 70 (28) minutes for the ketorolac group, 62 (16) minutes for the bupivacaine group, and 65 (16) minutes for the placebo group.
Our study found pain scores with
4. Incidence
1997
n*
Ketorolac
n*
30 30
6.27 5 4.89 (O-19) 0.36 + 0.49 (O-11
31 31
4.19 2 2.93 (O-10)
27
21 deviation
Bupivacaine
n*
Placebo
4.11 i- 3.51 (O-151 0.23 2 0.43 (O-l)
33 33
5.33 + 4.40 (O-15) 0.42 + 0.50 (O-1)
3.15 2 2.09 (O-8)
28
3.07 k 2.29 (O-81
Tool et al
Postoperative
(range).
Pain
Re2ieJ
733
R$erences 1. Yoon
IB, Wheeless
CR,
King
TM.
A preliminary
report
on a new
laparoscopic sterilization approach: The silicone rubber band technique. Am J Obstet Gynecol 1974;120:132-6. 2. Peterson HB, Hulka J, Phillips JM, Surrey MW. Laparoscopic sterilization: American Association of Gynecologic Laparoscopists 1991 membership survey. J Reprod Med 1993;38:574-6. 3. Ziegler JS, Schneider GT, Caire AA. A comparison ring and laparoscopic tubal cauterization. J Reprod
237-8. 4. Yoon IB, King falope
Parmley TH. procedure.
CJ, Daily HI, Marko MW, sterilization: Experience
A two year experience Am J Obstet Gynecol Richardson DC. with a silastic
LP. Incidence of pain among sterilization by electrocoagulation,
Non electrical band. Obstet
sterilization.
734
Tool
KT, Tomasi tube. Fertil W. Post-operative
Scott
et al
Med
pain
TB, Lippes J. Prostaglandins in the Steril 1974;25:250-5. analgesia following laparoscopic
J 1979;24:220.
Postoperative Pain ReliqF
Jadad AR. Reduction with local bupivacaine: trial. Br J Obstet Gynaecol BL. Intramuscular laparoscopic
13. Van Ee R, Hemrika DJ, DeBlok ketoprofen and mesosalpinx after laparoscopic sterilization. 14. Melzack Ii. The McGill pain methods.
Pain
ketorolac sterilisation.
of pain after A randomised, l994;101:443-6. for postoperative Anaesth lntensive
S, Vanderlinden C, Lip H. Effects of infiltration on postoperative pain Obstet Gynecol 1996;88:568-72. questionnaire: Major properties and
1975;1:277-99.
Address
reprint
requests
to:
Dorothy Kammerer-Doak,
MD and Gynecology University qf New Mexico Hospital 2211 Lomas NE Albuquerque, NM 87131 Department
4 Obstetrics
women undergoing the spring-loaded
clip, and the tubal ring. Am J Obstet Gynecol 1979;135:397-407. 8. Brodie BL, Casper RF. Prostaglandins mediate postoperative in falope ring sterilization. Am J Obstet Gynecol 1985;151:175-7. 9. Ogra SS, Kirton human fallopian 10. Leggat IT, Barr
JM,
with the 1977;127:
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Received April 23, 1997. Received in revised form Accepted July 18, 1997.
Copyright Gynecologists.
0
1997
by
Published
The
]uly 7, 2997.
American
by Elsevier
College Science
of Obstetricians
and
Inc.
Obstetrics & Gynecology