Methadone + Ketamine for Pain Management in Liver Transplant (RELIEF-LT Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByRyan Nazemian, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Lahey Clinic

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults undergoing a deceased donor liver transplant, aiming to reduce post-surgery pain. Participants will be observed throughout their hospital stay.

Inclusion Criteria

I am 18 years old or older.

I am receiving a liver transplant from a deceased donor.

Exclusion Criteria

I am receiving a liver transplant from a living donor.

I am receiving part of a liver in my transplant.

I am on a breathing machine before my liver transplant surgery.

I have severe brain issues due to liver problems.

I have a history of prolonged QT syndrome.

I am currently on high doses of medication to maintain my blood pressure or sedation.

I need a liver transplant due to sudden liver failure.

Participant Groups

The study tests if methadone and ketamine during surgery can lessen pain and affect mental clarity after the procedure, compared to standard pain management practices.

2Treatment groups

Experimental Treatment

Active Control

Group I: M+K groupExperimental Treatment2 Interventions

Participants in this arm will receive the intervention with methadone and ketamine

Group II: SOC groupActive Control2 Interventions

Participants in this arm will receive the standard of care with combination of hydromorphone and fentanyl