Opioid Use After Laparoscopic Salpingectomy (NCT06434233) | Clinical Trial Compass
RecruitingPhase 4
Opioid Use After Laparoscopic Salpingectomy
United States38 participantsStarted 2024-04-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically about opioid use after laparoscopic salpingectomy — does my planned procedure match exactly what's being studied, and would that make me a good candidate to discuss enrolling?
2Since this is a Phase 4 trial, does that mean the safety of the treatments being compared is already fairly well established, and what does that mean for my personal risk if I participate?
3The trial is measuring post-operative pain scores — does that mean I might be assigned to a group that receives less opioid pain relief than I'd normally get, and how would my pain be managed if it becomes severe?
4Are there standard pain management protocols after laparoscopic salpingectomy that are already proven to work well, and would I be better off just following one of those rather than enrolling in this study?
5Given that this trial is still actively recruiting, how long would I need to be involved, and what extra visits or reporting of my pain scores would be required of me beyond my normal post-operative care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numeric post-operative pain score
Timeframe: post-operative day 1 and post-operative day 7