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Taking people in United StatesPhase 2

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

Key facts

Who runs it
Johns Hopkins University
Where
Baltimore, United StatesSee the 2 sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
100 people, planned
Started
7 Mar 2025
Expected to end
Dec 2026
Type of study
Interventional, 2 groups
Treatments tested
  • Methadone
Record updated
12 January 2026

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Chronic pain syndromes patients including fibromyalgia
  • Allergy or other contraindication to the prescribed medications such as methadone, fentanyl, acetaminophen or oxycodone
  • Conversion to laparotomy
  • Severe Obstructive Sleep Apnea (OSA)
  • Pregnant/breastfeeding patients

Where in United States

  • The Johns Hopkins Bayview Medical CenterBaltimore, United StatesContact: Mostafa BorahayTaking people
  • The Johns Hopkins HospitalBaltimore, United StatesContact: Mostafa BorahayTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 2 groups in the trial

  • MethadoneTreatment being tested

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

  • Short-Acting OpioidOther group

    Standard intra-operative IV shorter acting opioids

    Treatment: Methadone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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.
Record updated
12 January 2026