CompletedPhase 4

Reducing Pain With Methadone and Ketamine in Liver Transplant

United States50 participantsStarted 2025-06-30

Plain-language summary

The goal of this clinical trial is to learn if using methadone and ketamine during an adult deceased donor liver transplant can help decrease pain after surgery. The main questions it aims to answer are: * What impact does using methadone and ketamine during a deceased donor liver transplant have on pain after surgery? * Does the use of methadone and ketamine also have an impact on mental confusion (delirium) after surgery? Researchers will compare the use of methadone and ketamine to standard of care to see if the two drugs work to decrease pain and impact delirium after liver transplant. Participants will: * Receive either methadone and ketamine or standard of care during their deceased donor liver transplant. * Allow researchers to follow medical care throughout inpatient stay.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients ≥ 18 years of age at the time of LT. * Undergoing LT from a deceased donor. * Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion criteria: * Living donor liver transplantation (LDLT). * Split liver transplantation (isolated right or left lobe). * Acute liver failure (ALF) as the indication for LT. * Repeat (redo) liver transplant * Simultaneous liver and kidney transplant (SLK) * Sedation or high vasopressor use. * Subject is intubated and/or mechanically ventilated prior to entering the operating room for LT. * Severe Hepatic encephalopathy * History of psychiatric disorders such as schizophrenia or bipolar mood disorders * History of chronic opioid use, substance abuse or opioid maintenance therapies * Any history of allergic reaction to any of the study drugs History of Brugadda, prolonged QT syndrome or QTc in preoperative setting * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data * Prisoner * Pregnant person * Operational Exclusion Criterion: Subjects will not be enrolled if study personnel required for protocol execution (e.g., study investigator, research staff or pharmacy staff) are unavailable at the time of transplantation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative Pain

Timeframe: 8, 16, 24, 32, 40 and 48hours post-surgery finish

Postoperative Pain

Timeframe: 8, 16, 24, 32, 40 and 48hours post-surgery finish

Trial details

NCT IDNCT06868589

SponsorLahey Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

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