Recruiting
Phase 2

Methadone

Sponsor:

Johns Hopkins University

Code:

NCT06536517

Conditions

Fibroid Uterus

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methadone

Study Details

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).

Conditions

Fibroid Uterus

Study ID

NCT06536517

Start date

Mar 7, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Methadone

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mostafa Borahay, MD, MBA, PhD

410-550-0337mboraha1@jhmi.edu

Locations

The Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

The Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Johns Hopkins University

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Keywords

  • hysterectomy
  • methadone
  • opioids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-01-12.