Postoperative shoulder pain is often reported to be particularly bothersome after laparoscopy. The benefits of local anesthetic, such as bupivacaine, applied to subcutaneous tissue for general postoperative pain management after surgery is well established. However, there have been no studies on sprayed bupivacaine over the diaphragm to reduce shoulder pain in laparoscopic surgery. The purpose of the study is to evaluate if sprayed infra-diaphragmatic bupivacaine compared to placebo (saline) will improve postoperative shoulder pain in patients undergoing benign laparoscopic gynecologic surgery. The entire study will be conducted at Cedar Sinai Medical Center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
100
Prior to desufflation of the abdomen during the laparoscopic gynecologic procedure, the surgeon will instill 30mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) laparoscopically aiming to cover the diaphragm with liquid.
Cedars Sinai Medical Center
Los Angeles, California, United States
Post-operative shoulder pain scores
Reported right shoulder pain score using visual analog score (VAS) 24 hours postoperatively Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis = pain scores will be lower among the bupivacaine with epinephrine group Assessed using the validated 100-mm scale with a range of 0-10 (11-point numerical rating scale), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis
Time frame: 24 hours postoperatively
Post-operative generalized pain scores
Post-operative generalized pain scores (superiority): Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= pain scores will be lower among the bupivacaine with epinephrine group First and last reported generalized pain score in post-anaesthesia care unit (PACU) using numerical rating score Assessed using the validated 11-point numerical rating scale (0-10), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis
Time frame: up to 6 hours in post-anaesthesia care unit (PACU)
Total analgesic requirements in post-anaesthesia care unit (PACU) in morphine equivalents
Calculated in morphine milligram equivalents (continuous data) Analyzed using the Kruskall-Wallis test (assuming non-normal data) Data will be presented as median (range)
Time frame: up to 6 hours in post-anaesthesia care unit (PACU)
Length of stay in post-anaesthesia care unit (PACU)
Length of stay in post-anaesthesia care unit (PACU) (superiority): Null hypothesis = PACU length of stay will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= PACU length of stay will be shorter in the bupivacaine with epinephrine groups Documented in minutes (continuous data) Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed
Time frame: up to 6 hours in post-anaesthesia care unit (PACU)
Post-operative shoulder pain scores at home
Daily reported post-operative shoulder pain scores at home (superiority): Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis = pain scores will be lower among the bupivacaine with epinephrine group Assessed using the validated 100-mm scale with a range of 0-10 (11-point numerical rating scale), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis
Time frame: 5 days postoperatively
Post-operative opioid use
Post-operative opioid use (superiority): Null hypothesis = post-op opioid use will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= post-op opioid use will be lower among the bupivacaine with epinephrine group Number of pills used reported by patient (interval data) Analyzed using the Kruskall-Wallis test Data will be presented as median (range)
Time frame: 1 week postoperative
Surgical outcome: EBL
Surgical outcomes: EBL (mL) Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group Continuous variables: estimated blood loss Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed
Time frame: up to 8 hours
Surgical outcome: operative time
Surgical outcomes: operative time (minutes) Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group Continuous variables: operative time, estimated blood loss Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed
Time frame: up to 8 hours
Surgical outcome: intraoperative complications
Surgical outcomes: intraoperative complications Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group Binary data: Surgical complications (yes/no) Analyzed using chi-square test
Time frame: within 1 week of surgery
Surgical outcomes: conversion to laparotomy
Surgical outcomes: conversion to laparotomy Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group Binary data: conversion to laparotomy (yes/no) Analyzed using chi-square test
Time frame: within 6 hours of surgery start time
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