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RECRUITING
NCT06434233
PHASE4

Opioid Use After Laparoscopic Salpingectomy

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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.

Official title: A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-04-25

Completion Date

2026-11

Last Updated

2025-11-12

Healthy Volunteers

Yes

Interventions

DRUG

Acetaminophen

All patients will receive Acetaminophen 500 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge. All patients will be instructed to take Acetaminophen around the clock for the first 72 hours and as needed thereafter.

DRUG

Ibuprofen

All patients will receive Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge. All patients will be instructed to take Ibuprofen around the clock for the first 72 hours and as needed thereafter.

DRUG

Oxycodone

Patients randomized to Arm 1 will receive Oxycodone 5 mg orally every 4 hours as needed x 12 tablets at post-operative discharge Patients randomized to Arm 2 will not receive an Oxycodone prescription at post-operative discharge. However, participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of Oxycodone as in arm 1

Locations (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States