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Clinical Trial NCT07400146 for Postoperative Pain, Shoulder Pain is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy Phase 4 100
Clinical Trial NCT07400146 is designed to study Prevention for Postoperative Pain, Shoulder Pain. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 1 February 2026 until the study accrues 100 participants. Led by Cedars-Sinai Medical Center, this study is expected to complete by 1 August 2026. The latest data from ClinicalTrials.gov was last updated on 10 February 2026.
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 eval...Show More
Official Title
Instillation of Bupivacaine With Epinephrine Over Diaphragm to Reduce Postoperative Shoulder Pain Following Benign Gynecologic Laparoscopic Surgery: A Randomized Control Trial
Conditions
Postoperative PainShoulder PainPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- STUDY00003947
NCT ID Number
Start Date (Actual)
2026-02
Last Update Posted
2026-02-10
Completion Date (Estimated)
2026-08
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Laparoscopy
Gynecologic surgery
Bupivacaine
Gynecologic surgery
Bupivacaine
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBupivacaine with epinephrine Participants randomized to this arm will have 30 mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) placed over the diaphragm laparoscopically at the conclusion of the laparoscopic gynecologic procedure. | Instillation 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. |
No InterventionNo intervention No additional intervention will be performed. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 24 hours postoperatively |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 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) | 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 | 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 | 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) | 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 | 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 | 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 | 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 | within 6 hours of surgery start time |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
- 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.
- 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
Cedars-Sinai Medical CenterStudy Responsible Party
Kelly Wright, Principal Investigator, Division Director of Minimally Invasive Gynecologic Surgery, Cedars-Sinai Medical Center
Study Central Contact
Contact: Ogechukwu Ezike, MD, 3473371181, [email protected]
Contact: Kelly Wright, MD, [email protected]
1 Study Locations in 1 Countries
California
Cedars Sinai Medical Center, Los Angeles, California, 90048, United States
Ogechukwu Ezike, MD, Contact, 3473371181, [email protected]
Ogechukwu Ezike, MD, Sub-Investigator
Kelly Wright, MD, Principal Investigator