Reducing Pain With Methadone and Ketamine in Liver Transplant
- Conditions
- Liver Transplantation
- Interventions
- Registration Number
- NCT06868589
- Lead Sponsor
- Lahey Clinic
- 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.
- Detailed Description
Pain control following liver transplantation (LT) has been the subject of interest of many research projects due to invasive nature of the procedure, significant comorbidities of recipients, effect of hepatic metabolism on many common pain medications and difficulties in performing some neuraxial and regional techniques given patient coagulopathy. Some newer regional nerve blocks such as External Oblique Intercostal (EOI) block has also been successfully utilized in pain management of patients undergoing liver resections but their utilization in perioperative setting for high-MELD patients and after-hour operations are limited. Methadone and ketamine are well-known drugs that have been recently emerged as components of new pain management pathways in many open surgeries due to their availability, cost, well-known metabolism, good safety profile and prolonged effects. Evidence has emerged that their use is associated with decreased likelihood of development of chronic pain and need for long term opioids. The combination of methadone and ketamine has been shown to be superior to opioids alone due to synergistic effect on N-methyl-d-aspartate and μ-opioid receptors. But these medications have not been extensively studied in LT recipients except for a few case reports and small studies. Current standards of care for intraoperative pain management during LT are systemic short and medium long-acting opioids such as fentanyl and hydromorphone which both have numerous concerns such as respiratory depression and opioid dependency. The aim of this study is to prospectively evaluate the effect of intraoperative methadone and ketamine administration on postoperative pain in liver transplant recipients. These drugs have been safely used during liver transplantation at LHMC and other centers and showed to be effective and safe, but the exact dosing and timing of administration requires further studies.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
Living donor liver transplantation (LDLT).
- Split liver transplantation (isolated right or left lobe).
- Acute liver failure (ALF) as the indication for LT.
- Simultaneous liver and kidney Transplant (SLK)
- Repeat liver transplant
- 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 substance abuse or opioid maintenance therapies
- Any history of allergic reaction to methadone or ketamine
- History of 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description M+K group Methadone Participants in this arm will receive the intervention with methadone and ketamine M+K group ketamine Participants in this arm will receive the intervention with methadone and ketamine SOC group Hydromorphone Participants in this arm will receive the standard of care with combination of hydromorphone and fentanyl SOC group fentanyl Participants in this arm will receive the standard of care with combination of hydromorphone and fentanyl
- Primary Outcome Measures
Name Time Method Postoperative Pain 8, 16, 24, 32, 40 and 48hours post-surgery finish Subjective postoperative pain scores measured as 0-10 (10 being the worst pain)
- Secondary Outcome Measures
Name Time Method 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 Duration of length of stay in intensive care unit in hours
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 Duration of length of stay in the hospital in 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 Incidence of postoperative delirium measured by standard CAM-ICU scores, ICD-10 diagnosis of delirium, any use of anti-agitation medication such as haloperidol, dexmedetomidine or seroquel
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 Any significant respiratory complications such as re-intubation, need for invasive ventilation such as BIPAP or CPAP
Postoperative adjunct pain modalities Post surgery finish until discharge from intensive care unit, or date of death from any cause, whichever came first, assessed up to 30 days Incidence of usage of any additional pain modalities such as nerve blocks, neuraxial anesthesia, non-narcotic pain medications such as additional ketamine dose, ketorolac, methocarbamol, ketorolac, etc
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 Any need for narcotics reversal agents such as Naloxone after administration of study drugs
Related Research Topics
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Trial Locations
- Locations (1)
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States