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Not yet recruiting NCT07400146

Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy

Phase IV Interventional Postoperative Pain Shoulder Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Instillation of Bupivacaine with epinephrine over the diaphragm.
Who it may be relevant to
Registry conditions: Postoperative Pain, Shoulder Pain. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug 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.

Primary outcome measures

  • Post-operative shoulder pain scores [Time frame: 24 hours postoperatively]
Secondary outcome measures (9)
  • Post-operative generalized pain scores [Time frame: up to 6 hours in post-anaesthesia care unit (PACU)]
  • Total analgesic requirements in post-anaesthesia care unit (PACU) in morphine equivalents [Time frame: up to 6 hours in post-anaesthesia care unit (PACU)]
  • Length of stay in post-anaesthesia care unit (PACU) [Time frame: up to 6 hours in post-anaesthesia care unit (PACU)]
  • Post-operative shoulder pain scores at home [Time frame: 5 days postoperatively]
  • Post-operative opioid use [Time frame: 1 week postoperative]
  • Surgical outcome: EBL [Time frame: up to 8 hours]
  • Surgical outcome: operative time [Time frame: up to 8 hours]
  • Surgical outcome: intraoperative complications [Time frame: within 1 week of surgery]
  • Surgical outcomes: conversion to laparotomy [Time frame: within 6 hours of surgery start time]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Cedars Sinai Medical Center — Los Angeles

Publications

  • Hammer A, Rositch AF, Kahlert J, Gravitt PE, Blaakaer J, Sogaard M. Global epidemiology of hysterectomy: possible impact on gynecological cancer rates. Am J Obstet Gynecol. 2015 Jul;213(1):23-29. doi: 10.1016/j.ajog.2015.02.019. Epub 2015 Feb 25. PMID 25724402
  • Alperin M, Kivnick S, Poon KY. Outpatient laparoscopic hysterectomy for large uteri. J Minim Invasive Gynecol. 2012 Nov-Dec;19(6):689-94. doi: 10.1016/j.jmig.2012.06.007. PMID 23084671
  • Driessen SR, Baden NL, van Zwet EW, Twijnstra AR, Jansen FW. Trends in the implementation of advanced minimally invasive gynecologic surgical procedures in the Netherlands. J Minim Invasive Gynecol. 2015 May-Jun;22(4):642-7. doi: 10.1016/j.jmig.2015.01.026. Epub 2015 Feb 3. PMID 25655043
  • Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003677. doi: 10.1002/14651858.CD003677.pub3. PMID 16625589
  • Jaschinski T, Mosch C, Eikermann M, Neugebauer EA. Laparoscopic versus open appendectomy in patients with suspected appendicitis: a systematic review of meta-analyses of randomised controlled trials. BMC Gastroenterol. 2015 Apr 15;15:48. doi: 10.1186/s12876-015-0277-3. PMID 25884671
  • Lirk P, Thiry J, Bonnet MP, Joshi GP, Bonnet F; PROSPECT Working Group. Pain management after laparoscopic hysterectomy: systematic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019 Apr;44(4):425-436. doi: 10.1136/rapm-2018-100024. Epub 2019 Feb 3. PMID 30914471
  • Vadivelu N, Mitra S, Narayan D. Recent advances in postoperative pain management. Yale J Biol Med. 2010 Mar;83(1):11-25. PMID 20351978
  • American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available. PMID 22227789

Identifiers

NCT: NCT07400146 · STUDY00003947

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗