Using methadone during laparoscopic hysterectomy to reduce opioid prescriptions
Official title: A Randomized Controlled Trial to Study the Effects of One-time Intra-operative Dosing of Methadone During Laparoscopic or Robotic Hysterectomy in Reducing Opioid Prescription.
Run by Johns Hopkins University · NCT06536517 · Data updated 2026-11-12
This study is trying to see if giving methadone during laparoscopic hysterectomy can help manage pain better and reduce the need for regular opioid painkillers after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Status | Recruiting |
| Started | March 7, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT06536517 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 18 and older undergoing minimally invasive hysterectomy for benign conditions.
✕Probably not a fit
Patients with chronic pain syndromes, long-term opioid use, or certain contraindications will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of administering a single dose of methadone during laparoscopic hysterectomy to manage postoperative pain and reduce the need for opioid prescriptions. The hypothesis is that methadone, with its longer-lasting analgesic properties, can minimize the reliance on short-acting opioids typically prescribed after surgery. By comparing outcomes between patients receiving methadone and those receiving standard short-acting opioids, the study aims to evaluate pain control, opioid consumption, and potential side effects. This approach seeks to address the growing concern of opioid overprescription and abuse in the postoperative setting.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for opioid prescriptions after surgery, thereby lowering the risk of opioid abuse and its associated complications.
How similar studies have gone: While the use of methadone for pain management in other surgical contexts has shown promise, its application in gynecological surgeries like hysterectomy is relatively novel and not extensively studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals with a uterus * Age 18 years old and above * Undergoing minimally invasive (laparoscopic or robotic) hysterectomy with ovarian preservation * Benign indications for hysterectomy * 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 * Patients currently on agonist-antagonist medications (e.g. buprenorphine) * Patients taking a selective serotonin reuptake inhibitor or monoamine oxidase inhibitor * Conversion to laparotomy * Allergy or other contraindication to the prescribed medications such as methadone, fentanyl, acetaminophen or oxycodone * Severe Obstructive Sleep Apnea (OSA) * Pregnant/breastfeeding patients
Where it's running
-
The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States Recruiting -
The Johns Hopkins Hospital
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Mostafa Borahay, MD, MBA, PhD — Study Principal Investigator
- Study coordinator: Mostafa Borahay, MD, MBA, PhD
- Email: mboraha1@jhmi.edu
- Phone: 410-550-0337
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.