Fibroid UterusPhase 2NCT06536517
The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.
A Phase 2 study testing Methadone in people with Fibroid Uterus, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroid Uterus
- What is being tested?
- Methadone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Mostafa Borahay
- Recruiting
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Mostafa Borahay
About this study
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.
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).
Read the detailed description
Problem:
The relief of moderate to severe postoperative pain in surgeries including abdominal surgeries continues to pose a major therapeutic dilemma. The traditional and most common therapy is the administration of short-acting opioid analgesics, intra-operative and post-operative, at intervals every 3-4 hours. However, the use of opioids with relatively short plasma half-lives at varying intervals may lead to various fluctuating drug concentrations in plasma, and side effects including respiratory, longer hospitalizations, delayed ambulation, inadequate pain relief and potential avenues for abuse. Identifying a more efficient and safer therapy for intraoperative pain analgesia can be helpful in controlling pain requirements in the post-operative setting.
In major inpatient and ambulatory surgeries, intraoperative single-dose methadone, through its unique pharmacology, has been shown to produce better analgesia, reduce opioid use and minimize adverse side effects compared with conventional repeated dosing of short-duration opioids. Additionally, methadone is theorized to be an N-methyl-D-aspartate (NMDA) receptor noncompetitive antagonist, which may contribute to its increase in analgesic potential as compared with fentanyl analogues. Finally, it has been shown to improve ambulation in the post operative anesthesia setting and pain control in chronic pain patients. The study of intra-operative methadone has not been extensively studied for gynecology surgeries, but one study has shown the decrease of mean opioid consumption post operatively after receiving one dose of intra-operative methadone compared to shorter acting opioids in same-day laparoscopic myomectomy. Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of longer opioid analgesics intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries and could minimize the need for additional post-operative and outpatient opioid prescriptions.
This study aims at addressing the requirement for postoperative opioid prescription after intraoperative longer acting vs shorter acting opioids in laparoscopic hysterectomy.
Hypothesis:
Single dose of intra-operative methadone is an adequate potential in treating post-operative pain after laparoscopic total hysterectomy surgeries, reducing the additional need for post-operative and outpatient opioid prescriptions and decreasing the adverse effects associated with opioid consumption.
Importance of research:
Given the increasing opioid abuse and over-prescription post-operatively, an effort must be made to determine whether one time dosing of longer opioid analgesics intraoperatively in conjunction with non-opioid multimodal medications is adequate to treat postoperative pain after laparoscopic hysterectomy. Additionally, this intervention may decrease the need for additional prescriptions or unscheduled patient contacts.
- Conditions
- Fibroid Uterus
- Being tested
- Methadone
- Keywords
- hysterectomy, methadone, opioids
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight)
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Experimental | Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight) Receives: Drug: Methadone |
| Short-Acting Opioid | Other | Standard intra-operative IV shorter acting opioids Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total post-operative opioid requirements in oral morphine milligram equivalents (MME)
Total post-operative opioid requirements in oral morphine milligram equivalents (MME) in first 7 post operative days.
Measured: 1 week
Secondary outcomes (3)
Mobility and satisfaction of analgesia
Mobility and satisfaction of analgesia on post-operative day one and seven (binary question Y/N)
Measured: Post operative day 1, Post operative day 7
Number of unplanned returns to emergency room/clinic or patient initiated phone call regarding pain
Measured: 1 week
Overall satisfaction with pain control
0-10 scale (0- no pain, 10-worst pain)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start7 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mostafa Borahay, MD, MBA, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536517
- Sponsor's protocol ID
- IRB00459067
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06536517
- Acronym / sponsor ID
- IRB00459067
- Conditions
- Fibroid Uterus
- Keywords
- hysterectomy, methadone, opioids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Problem:
The relief of moderate to severe postoperative pain in surgeries including abdominal surgeries continues to pose a major therapeutic dilemma. The traditional and most common therapy is the administration of short-acting opioid analgesics, intra-operative and post-operative, at intervals every 3-4 hours. However, the use of opioids with relatively short plasma half-lives at varying intervals may lead to various fluctuating drug concentrations in plasma, and side effects including respiratory, longer hospitalizations, delayed ambulation, inadequate pain relief and potential avenues for abuse. Identifying a more efficient and safer therapy for intraoperative pain analgesia can be helpful in controlling pain requirements in the post-operative setting.
In major inpatient and ambulatory surgeries, intraoperative single-dose methadone, through its unique pharmacology, has been shown to produce better analgesia, reduce opioid use and minimize adverse side effects compared with conventional repeated dosing of short-duration opioids. Additionally, methadone is theorized to be an N-methyl-D-aspartate (NMDA) receptor noncompetitive antagonist, which may contribute to its increase in analgesic potential as compared with fentanyl analogues. Finally, it has been shown to improve ambulation in the post operative anesthesia setting and pain control in chronic pain patients. The study of intra-operative methadone has not been extensively studied for gynecology surgeries, but one study has shown the decrease of mean opioid consumption post operatively after receiving one dose of intra-operative methadone compared to shorter acting opioids in same-day laparoscopic myomectomy. Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of longer opioid analgesics intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries and could minimize the need for additional post-operative and outpatient opioid prescriptions.
This study aims at addressing the requirement for postoperative opioid prescription after intraoperative longer acting vs shorter acting opioids in laparoscopic hysterectomy.
Hypothesis:
Single dose of intra-operative methadone is an adequate potential in treating post-operative pain after laparoscopic total hysterectomy surgeries, reducing the additional need for post-operative and outpatient opioid prescriptions and decreasing the adverse effects associated with opioid consumption.
Importance of research:
Given the increasing opioid abuse and over-prescription post-operatively, an effort must be made to determine whether one time dosing of longer opioid analgesics intraoperatively in conjunction with non-opioid multimodal medications is adequate to treat postoperative pain after laparoscopic hysterectomy. Additionally, this intervention may decrease the need for additional prescriptions or unscheduled patient contacts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone | Experimental | Drug: MethadoneIntra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight) |
| Short-Acting Opioid | Other | Drug: MethadoneStandard intra-operative IV shorter acting opioids |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethadoneIntra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight) | Drug | Methadone, Short-Acting Opioid |
Primary outcome
Total post-operative opioid requirements in oral morphine milligram equivalents (MME)
Time frame: 1 week
Total post-operative opioid requirements in oral morphine milligram equivalents (MME) in first 7 post operative days.
3 secondary outcomes
Mobility and satisfaction of analgesia
Time frame: Post operative day 1, Post operative day 7
Number of unplanned returns to emergency room/clinic or patient initiated phone call regarding pain
Time frame: 1 week
Overall satisfaction with pain control
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mostafa Borahay, MD, MBA, PhD principal investigator
Study Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methadone in people with Fibroid Uterus, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Borahay, MD, MBA, PhD (410-550-0337, mboraha1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total post-operative opioid requirements in oral morphine milligram equivalents (MME) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.