Evaluating pain management after laparoscopic tubal sterilization
A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy
This study is testing whether a combination of non-opioid pain medications can manage pain just as well as opioids after a laparoscopic tubal sterilization procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06434233 on ClinicalTrials.gov |
What this trial studies
This study evaluates patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures. It aims to determine if a multimodal, non-opioid pain control regimen is as effective as a regimen that includes opioids. The hypothesis is that with proper counseling and the use of non-opioid medications, the need for opioid prescriptions can be eliminated after laparoscopic salpingectomy. Participants will receive either acetaminophen and ibuprofen or oxycodone for pain management.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 and older undergoing laparoscopic or robotic salpingectomy for benign reasons.
Not a fit: Patients with chronic pain syndromes or those currently on long-term opioid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce reliance on opioids for pain management after surgery, minimizing the risk of opioid-related complications.
How similar studies have performed: Other studies have shown promising results with multimodal pain management approaches, suggesting this method could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Mostafa Borahay, MD — Johns Hopkins University
- Study coordinator: Mostafa Borahay, MD
- Email: mboraha1@jhmi.edu
- Phone: 4439970400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.