Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
Healthy Volunteers
ID06434233

A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy

Led by Johns Hopkins University · Updated on 2026-06-03

38

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare pain control methods after minimally invasive tubal sterilization procedures in women aged 18 and older. It evaluates whether a non-opioid pain management plan is as effective as the standard regimen that includes opioids. The goal is to see if pain can be managed without opioids, reducing the need for opioid prescriptions after laparoscopic salpingectomy. Participants are randomly assigned to one of two groups. One group receives the common post-operative pain treatment including acetaminophen, ibuprofen, and oxycodone as needed. The second group receives only acetaminophen and ibuprofen without an opioid prescription initially but may receive oxycodone if additional pain relief is needed. All patients are advised to use acetaminophen and ibuprofen regularly for the first 72 hours after surgery. During the study, participants report their pain levels on post-operative days 1 and 7. Researchers also assess satisfaction with pain relief and mobility, total narcotic use, side effects related to opioids, and any additional pain medication requests or unplanned medical care within 30 days after surgery. The study monitors these outcomes to understand the effectiveness and safety of non-opioid pain control compared to opioid use after surgery.

CONDITIONS

Brief Title

Opioid Use After Laparoscopic Salpingectomy

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with one or both fallopian tubes
  • Age 18 years old and above
  • Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization as the primary procedure
  • Salpingectomy or tubal sterilization performed for benign reasons
  • Agreeing to participate in the study
Not Eligible

You will not qualify if you...

  • Having chronic pain syndromes such as fibromyalgia
  • Current long-term opioid use lasting more than three months
  • Conversion to open surgery (laparotomy)
  • Allergy or contraindication to acetaminophen, oxycodone, or other prescribed medications
  • Salpingectomy performed with major gynecologic surgery like hysterectomy
  • Salpingectomy done to treat ectopic pregnancy
  • History of gastritis or gastrointestinal bleeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to discharge after surgery

Participants undergo a minimally invasive laparoscopic salpingectomy or tubal sterilization procedure and begin post-operative pain management.

1 visit (in-person) on the day of surgery

Treatment

Duration - Up to 7 days post-operative

Participants receive either an opioid-based or non-opioid post-operative pain control regimen with Acetaminophen and Ibuprofen scheduled around the clock for the first 72 hours and as needed thereafter. Participants in the non-opioid group may receive opioids if additional pain medication is needed.

1 baseline visit at discharge and 2 follow-up visits on post-operative day 1 and day 7

Follow-up

Duration - Up to 30 days post-operative

Participants are monitored for pain control satisfaction, mobility, narcotic consumption, opioid-related side effects, and any additional medical care requests related to post-surgical pain for up to 30 days after surgery.

Approximately 2 follow-up visits within 30 days after surgery

Trial Site Locations

Total: 1 location

1

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States, 21224

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Research Team

M

Mostafa Borahay, MD

S

Shannon Osborne, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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