Reducing Pain With Methadone and Ketamine in Liver Transplant

NCT06868589 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 20243140
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Liver Transplantation

Keywords

Liver Transplantation; Deceased Donor Liver Transplant; Postoperative Pain; Methadone; Ketamine; Perioperative Analgesia; Anesthesiology; Acute Pain; Transplant Surgery; Opioids

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain

  postoperative opioid consumption (measured as morphine milligram equivalents ((MME)) 48 hours after surgery

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

• Postoperative Pain

  Subjective postoperative pain scores measured as 0-10 (10 being the worst pain)

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

Secondary Outcomes (8)

• Length of stay in intensive care unit

  Post surgery finish until discharge from intensive care unit, or date of death from any cause, whichever came first, assessed up to 30 days

• Length of stay in hospital

  Post surgery finish until discharge from hospital, or date of death from any cause, whichever came first, assessed up to 30 days

• Delirium

  Post surgery finish until discharge from intensive care unit, or date of death from any cause, whichever came first, assessed up to 30 days

• Respiratory complications

  Post surgery finish until discharge from intensive care unit, or date of death from any cause, whichever came first, assessed up to 30 days

• Narcotics reversal agent

  Post surgery finish until discharge from intensive care unit, or date of death from any cause, whichever came first, assessed up to 30 days

Study Arms (2)

M+K group

EXPERIMENTAL

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

Drug: Methadone; Drug: ketamine

SOC group

ACTIVE COMPARATOR

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

Drug: Hydromorphone; Drug: fentanyl

Interventions

Methadone DRUG

Participants in this group will receive one bolus dose of intravenous Methadone and Ketamine at the start of operation

M+K group

ketamine DRUG

Participants in this group will receive one bolus dose of intravenous Methadone and Ketamine at the start of operation

M+K group

Hydromorphone DRUG

Participants in this group will receive standard of care for pain with either intravenous fentanyl and/or hydromorphone boluses during the procedure

SOC group

fentanyl DRUG

Participants in this group will receive standard of care for pain with either intravenous fentanyl and/or hydromorphone boluses during the procedure

SOC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (2)

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

NOT YET RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Methadone; Ketamine; Hydromorphone; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ryan Nazemian, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Nazemian, MD, PhD

CONTACT

781-813-0389; ryan.nazemian@lahey.org

Michael D Kaufman, MD

CONTACT

9787026578; michael.kaufman@bilh.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants won't be aware of the study arm and treatments they receive. The statistician will be masked on the treatment group during final study analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist: Division of Transplant, Director: Transplant Anesthesia Fellowship, Co-Director: Anesthesia Informatics

Model Details: Participants will be randomly assigned to either intervention or standard of care group at the ratio of 1:1

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 11, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)