Methadone + Ketamine for Pain Management in Liver Transplant

(RELIEF-LT Trial)

Overseen By Michael D Kaufman, MD

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.

Research Team

Ryan Nazemian, MD, PhD

Principal Investigator

Lahey Hospital and Medical Center, Department of Anesthesiology, Perioperative and Pain Medicine

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.

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

I am receiving a liver transplant from a living donor.

Any history of allergic reaction to methadone or ketamine

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

Treatment Details

Interventions

• Ketamine (NMDA Receptor Antagonist)
• Methadone (Opioid)

Trial Overview 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.

Participant Groups

Group I: M+K group Experimental Treatment 2 Interventions

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

Group II: SOC group Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Lahey Clinic

Lead Sponsor

Trials

74

Recruited

245,000+