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RECRUITING Phase 4 ClinicalTrials.gov

Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy

Sponsor: Cedars-Sinai Medical Center • ClinicalTrials.gov ID: NCT07400146

Registry updated: 2026-09-30
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Description

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

  • Instillation of Bupivacaine with epinephrine over the diaphragm (Drug)
    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.

Eligibility criteria

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

Conditions

Postoperative Pain Shoulder Pain

Locations

  • Cedars Sinai Medical Center — Los Angeles, California, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record