NCT06536517 The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.
| NCT ID | NCT06536517 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins University |
| Condition | Fibroid Uterus |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-03-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. This study aims to find the optimal pain medication plan during and after laparoscopic hysterectomy to eliminate long-term opioid use. Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of Methadone, a longer opioid analgesics, intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries. The investigators hypothesize that this could minimize the need for additional post-operative and outpatient opioid prescriptions and decrease the adverse effects that are associated with the consumption, including new opioid abuse. Intervention group will receive methadone intraoperatively while the other group would receive short-acting opioids (standard).
Eligibility 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
Contact & Investigator
Mostafa Borahay, MD, MBA, PhD
PRINCIPAL INVESTIGATOR
Study Principal Investigator
Frequently Asked Questions
Who can join the NCT06536517 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fibroid Uterus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06536517 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06536517 currently recruiting?
Yes, NCT06536517 is actively recruiting participants. Contact the research team at mboraha1@jhmi.edu for enrollment information.
Where is the NCT06536517 trial being conducted?
This trial is being conducted at Baltimore, United States, Baltimore, United States.
Who is sponsoring the NCT06536517 clinical trial?
NCT06536517 is sponsored by Johns Hopkins University. The principal investigator is Mostafa Borahay, MD, MBA, PhD at Study Principal Investigator. The trial plans to enroll 100 participants.