Methadone for Postoperative Pain in Breast Reconstruction

Overseen By Ethan Lester

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: University of Utah

Must not be taking: Opioids

Disqualifiers: Reoperations, Multiple procedures, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether methadone, administered during surgery, can reduce pain and the need for other painkillers after breast reconstruction surgery. The researchers aim to determine if methadone can smooth recovery and improve pain control. Participants will receive either methadone or a standard painkiller during surgery. Women who have undergone a mastectomy and are undergoing breast reconstruction using tissue from their abdomen might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in pain management.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have a chronic pain condition or use opioids regularly, you may not be eligible to participate.

Is there any evidence suggesting that methadone is likely to be safe for humans?

Research has shown that methadone is generally safe for use during surgery. In past studies, patients who received methadone during surgery required fewer additional painkillers afterward, suggesting that methadone might effectively manage pain.

These studies also found that methadone did not cause more side effects than other pain treatments, indicating its safety. However, methadone is still undergoing testing for this specific use and is not fully approved yet. This stage of testing usually indicates some confidence in its safety.

Overall, methadone appears promising as a safe option for managing pain after surgery, but more results from ongoing trials will provide clearer answers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard postoperative pain management options like opioids such as hydromorphone, methadone is unique because it provides long-lasting pain relief with a single dose. Most pain treatments after surgery require multiple doses, but methadone's extended action targets pain for a longer period, potentially reducing the need for additional medication. Researchers are excited about methadone because it may offer a more consistent and manageable approach to pain control while minimizing the risk of frequent dosing and associated side effects.

What evidence suggests that methadone might be an effective treatment for postoperative pain in breast reconstruction?

Research has shown that using methadone during surgery can effectively manage postoperative pain. In this trial, participants in the methadone group will receive a single dose of intravenous methadone within 30 minutes after anesthesia induction. Studies have found that a single dose of methadone can relieve pain more effectively than multiple doses of other short-term painkillers. For patients undergoing breast reconstruction, methadone significantly reduces the need for additional opioids in the days following surgery. It also helps lower overall opioid use, potentially leading to a smoother recovery. This suggests methadone could be a valuable option for improving pain management after breast reconstruction surgery. ^{1 3 4 5 6}

Who Is on the Research Team?

Alvin Kwok, MD, MPH

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Are You a Good Fit for This Trial?

This trial is for individuals undergoing autologous breast reconstruction after breast cancer, who are interested in potentially reducing their postoperative opioid use. Participants should be eligible for the surgery and willing to try methadone as part of pain management.

Inclusion Criteria

I am a woman aged 18 or older.

I am having breast reconstruction with tissue from my abdomen after a mastectomy.

Exclusion Criteria

I am having a mastectomy and immediate reconstruction.

I am having a breast reconstruction with my own tissue after a failed implant surgery.

I have been using opioids long-term before my procedure or have a chronic pain condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraoperative methadone or standard care during autologous breast reconstruction surgery

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored daily for opioid-related side effects and pain management satisfaction

up to 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Methadone

Trial Overview The study tests if giving methadone during surgery can help with pain control and reduce the need for opioids after surgery. It's a controlled trial where patients are randomly chosen to receive either methadone or standard care during their operation.

How Is the Trial Designed?

Group I: Intraoperative Methadone Experimental Treatment 1 Intervention

the methadone group will receive a single dose of intravenous methadone administered within 30 minutes after induction of anesthesia by the attending anesthesiologist. The standard dose will be 20 mg, except for patients under 60 kg or over 65 years of age, who will receive 15 mg.

Group II: Control Active Control 1 Intervention

The control group will not receive methadone and will instead receive a standard dose of 1 mg IV hydromorphone within the final 30-45 minutes of the procedure.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07092475

The Impact of Intraoperative Methadone on Postoperative ... This is a single-institution, randomized controlled trial to assess the effectiveness of intraoperative methadone on postoperative opioid ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40167055/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1vKcRI80qSZ3SfF9jZ6azm491XgClBkQmCFwLrG2c4aJ9SegQf&fc=None&ff=20250403100002&v=2.18.0.post9+e462414

Intraoperative Methadone: A New Enhanced Recovery ... Previous studies have shown that just one dose of methadone can achieve better analgesia than multiple doses of short-acting opioids. This study ...

3. habcentral.habcommunity.com habcentral.habcommunity.com/article/the-impact-of-intraoperative-methadone-on-perioperative-opioid-requirements-in-autologous-free-flap-breast-reconstruction?article_title=The%20Impact%20of%20Intraoperative%20Methadone%20on%20Perioperative%20Opioid%20Requirements%20in%20Autologous%20Free%20Flap%20Breast%20Reconstruction.&article_id=6317238

Intraoperative Methadone Reduces Opioid Use in Breast ... Intraoperative methadone significantly reduces inpatient opioid use after undergoing autologous breast reconstruction on POD-1, POD2, and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818024002010

Intraoperative methadone administration for total mastectomy Methadone was associated with significantly less perioperative opioid consumption than short-acting opioids. · Methadone was associated with less use of non- ...

5. thieme-connect.de thieme-connect.de/products/ejournals/pdf/10.1055/a-2717-5119.pdf

The Impact of Intraoperative Methadone on Perioperative ... The primary outcome was daily postoperative opioid requirements, recorded in morphine milligram equivalents (MME). Results A total of 112 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11917523/

Intraoperative methadone administration for total mastectomy The analysis demonstrated that methadone was associated with significantly lower intraoperative and postoperative opioid consumption as measured ...