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NCT06536517 · ClinicalTrials.gov registry record · Phase 2
The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.
A Phase 2 study of Fibroid Uterus, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT06536517: Recruiting Phase 2 study of Fibroid Uterus, sponsored by Johns Hopkins University.
NCT06536517 is a Phase 2 study of Fibroid Uterus that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 100 participants, roughly in line with the 93-participant average among 3 other Fibroid Uterus trials with a reported enrollment target. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06536517, a Phase 2 study of Fibroid Uterus, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
Total post-operative opioid requirements in oral morphine milligram equivalents (MME) in first 7 post operative days.
Conditions Studied
Interventions
- DRUG Methadone
Study Locations (2)
Maryland
- The Johns Hopkins Bayview Medical Center - Baltimore
- The Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-03-07 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT06536517 shows while recruiting
NCT06536517 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 93-participant average among 3 other Fibroid Uterus trials with a reported enrollment target.
The record links to 1 condition, with Fibroid Uterus appearing as the primary indexed condition, and to 1 intervention - of which Methadone is the first listed.
NCT06536517 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06536517 about?
NCT06536517 is a clinical study titled "The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.". 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 th...
What is the current status of trial NCT06536517?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-03-07. Estimated completion is 2026-12.
What conditions does trial NCT06536517 study?
This clinical trial studies the following conditions: Fibroid Uterus.
What interventions are being tested in trial NCT06536517?
The interventions under investigation include: Methadone (DRUG).
Who is sponsoring clinical trial NCT06536517?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06536517 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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