Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT07400146
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Postoperative Pain
  • Shoulder Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Bupivacaine 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.
  • No Intervention: No intervention
    No additional intervention will be performed.

Primary Outcome Measure

Post-operative shoulder pain scores [ Time Frame: 24 hours postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Ogechukwu Ezike, MD
[email protected]
3473371181
Ogechukwu Ezike, MD (SUB_INVESTIGATOR)
Kelly Wright, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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