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Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy

RecruitingPhase 4Ages 18 Years - anyFemaleCedars-Sinai Medical Center
NCT07400146 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Instillation of Bupivacaine with epinephrine over the diaphragm
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Where

1 site
Cedars Sinai Medical Center
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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