Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methadone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Methadone
- description
- Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight)
- interventionNames
- Drug: Methadone
- type
- OTHER
- label
- Short-Acting Opioid
- description
- Standard intra-operative IV shorter acting opioids
- interventionNames
- Drug: Methadone
Primary outcomes (1)
- measure
- Total post-operative opioid requirements in oral morphine milligram equivalents (MME)
- timeFrame
- 1 week
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available