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Not Yet RecruitingNCT07400146

Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy

Instillation of Bupivacaine With Epinephrine Over Diaphragm to Reduce Postoperative Shoulder Pain Following Benign Gynecologic Laparoscopic Surgery: A Randomized Control Trial

Status
Not Yet Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Cedars-Sinai Medical Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGInstillation of Bupivacaine with epinephrine over the diaphragmPrior 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.

Timeline

Start date
2026-02-01
Primary completion
2026-07-01
Completion
2026-08-01
First posted
2026-02-10
Last updated
2026-02-10

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07400146. Inclusion in this directory is not an endorsement.