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.

NCT06536517 Phase 2 RECRUITING

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).

Details

Lead sponsor	Johns Hopkins University
Phase	Phase 2
Status	RECRUITING
Enrolment	100
Start date	2025-03-07
Completion	2026-12

Conditions

• Fibroid Uterus

Interventions

• Methadone

Primary outcomes

• Total post-operative opioid requirements in oral morphine milligram equivalents (MME) — 1 week
  Total post-operative opioid requirements in oral morphine milligram equivalents (MME) in first 7 post operative days.

Countries

United States