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NCT06434233PHASE4RecruitingAccepts Healthy Volunteers

Opioid Use After Laparoscopic Salpingectomy

Johns Hopkins University

Start Date

4/25/2024

Completion Date

11/1/2026

Summary

The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids. The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.

Detailed Description

This study is designed as a non-inferiority trial comparing a non-opioid post-operative pain control regimen to the standard opioid pain control regimen for post-operative salpingectomy patients. A non-inferiority margin of 2 units was selected, such that the experimental treatment will be considered non-inferior if the lower bound of the confidence interval for the treatment difference remains above a 2 point difference in reported pain scores.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Individuals with a fallopian tube (unilateral and/or bilateral) * Age 18 years old and above * Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure * Benign indications for salpingectomy/tubal sterilization * Agreeing to participate Exclusion Criteria: * Chronic pain syndromes patients including fibromyalgia * Patients currently on long-term (i.e. for more than three months) opioid use * Conversion to laparotomy * Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone * Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc) * Salpingectomy performed for treatment of ectopic pregnancy * Patients with a history of gastritis and/or GI bleeding

Interventions

DRUG

Acetaminophen

DRUG

Ibuprofen

DRUG

Oxycodone

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Conditions

Opioid UsePost-operative PainSterility, Female

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland 21224

United States