Postoperative Pain, Shoulder Pain
Conditions
Keywords
Laparoscopy, Gynecologic surgery, Bupivacaine
Brief summary
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.
Interventions
DRUGInstillation of Bupivacaine with epinephrine over the diaphragm
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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants are randomized into either the treatment arm with placement of bupivacaine with epinephrine over the diaphragm or the no intervention arm. Participants are blinded to whether or not they received the intervention.
Intervention model description
Randomized control trial, single blind study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provide a signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * 8 years of age or older * Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Exclusion criteria
* Pregnancy * Urgent/non-scheduled surgery * Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure) * Baseline shoulder pain * Baseline opioid use * Baseline of chronic pain syndrome * Conversion to open surgery * Allergy or intolerance to bupivacaine, lidocaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen * Planned post-operative admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative shoulder pain scores | 24 hours postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative generalized pain scores | up to 6 hours in post-anaesthesia care unit (PACU) | 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 |
| Total analgesic requirements in post-anaesthesia care unit (PACU) in morphine equivalents | up to 6 hours in post-anaesthesia care unit (PACU) | Calculated in morphine milligram equivalents (continuous data) Analyzed using the Kruskall-Wallis test (assuming non-normal data) Data will be presented as median (range) |
| Length of stay in post-anaesthesia care unit (PACU) | up to 6 hours 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 |
| Post-operative shoulder pain scores at home | 5 days postoperatively | 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 |
| Post-operative opioid use | 1 week postoperative | 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) |
| Surgical outcome: EBL | up to 8 hours | 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 |
| Surgical outcome: operative time | up to 8 hours | 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 |
| Surgical outcome: intraoperative complications | within 1 week of surgery | 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 |
| Surgical outcomes: conversion to laparotomy | within 6 hours of surgery start time | 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 |
Countries
United States
Contacts
CONTACTOgechukwu Ezike, MD
CONTACTKelly Wright, MD
Outcome results
None listed