The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06536517
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fibroid Uterus

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methadone — DRUG
    Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight)

Study Details

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).

Key Dates

Start date
Mar 7, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Methadone
    Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight)
  • Other: Short-Acting Opioid
    Standard intra-operative IV shorter acting opioids

Primary Outcome Measure

Total post-operative opioid requirements in oral morphine milligram equivalents (MME) [ Time Frame: 1 week ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224
Mostafa Borahay
The Johns Hopkins HospitalBaltimoreMaryland21287
Mostafa Borahay

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