Fibroid Uterus study: Methadone
Official title The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.
ClinicalTrials.gov ID: NCT06536517
What this study is testing
What is Methadone?
An investigational single‑dose IV medication being studied to reduce postoperative opioid use after laparoscopic hysterectomy for fibroid uterus.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether giving methadone once during surgery can lower the need for opioids after the operation and reduce related side effects.
- Who it's for
- Women who are having a laparoscopic hysterectomy because of fibroids.
- What's involved
- Participants will receive either a single dose of methadone during surgery or the usual short‑acting opioid. After surgery they may have follow‑up visits and pain assessments.
- Time commitment
- The study lasts from the day of surgery through the postoperative recovery period, with scheduled follow‑up visits as needed.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.