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The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.
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.
Who can join
Ages 18 and older · Women
Full eligibility criteria
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
About the study
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).
What is being tested
- Methadone (drug)
Sponsor: Johns Hopkins University · Participants: 100 · Started: Mar 7, 2025
Contact the study team
- Mostafa Borahay, MD, MBA, PhD · Phone: 410-550-0337
Official record on ClinicalTrials.gov — NCT06536517
Locations in the U.S.
| Maryland | The Johns Hopkins Bayview Medical Center, Baltimore The Johns Hopkins Hospital, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.