NCT07485803 · AdventHealth
Methadone in the Management of Post-Operative Pain in Total Knee Replacement
What this study is about
The goal of this study is to determine whether one dose of IV methadone given right before surgery will help patients' pain management after a total knee replacement and reduce the amount of pain medications taken in the weeks after surgery.
View original scientific description
The goal of this study is to determine whether one dose of IV methadone given right before surgery will help patients' pain management after a total knee replacement and reduce the amount of pain medications taken in the weeks after surgery.
Interventions
DRUG
Methadone
Subjects randomized to receive methadone will be given one dose of methadone 0.15mg/kg intravenously dosed based on ideal body weight administered by the anesthesia team prior to surgical incision
Primary outcome measures
Opioid use for 48 hours post-operatively
Time frame: 48 hours after TKA procedure
Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated informed consent from
- Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
- Unilateral total knee arthroplasty at Colorado Joint Replacement
- All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
Exclusion criteria
- Narcotic use in the past 6 weeks
- Current or previous history of drug and alcohol abuse
- Tobacco use in the previous 90 days
- Treatment with another investigational drug
- Patients that cannot receive spinal anesthesia
- Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)'
- Patients that are not able to go home after leaving the hospital and require a short-term rehabilitation facility
- Obstructive sleep apnea
- Morbid obesity (BMI \>40)
- Patients with liver disease.
- Significant kidney disease - stage 3 CKD or greater
- Pregnant or nursing females
- Baseline QTc \>480
- severe COPD (GOLD 3 or 4)
- home oxygen requirement
Where
- Denver, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations