Methadone in the Management of Post-Operative Pain in Total Knee Replacement
ConditionTotal Knee Arthroplasty
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-75
SponsorAdventHealth
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Age 21- 75
Unilateral total knee arthroplasty at Colorado Joint Replacement
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Methadone
DrugSubjects 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
Treatment groups
192 Participants
are divided into 2 treatment groupsGroup A: MethadoneExperimental treatment 1 intervention
Group B: No medicationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Opioid use for 48 hours post-operatively
Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption.
Time frame
48 hours after TKA procedureSecondary outcomes
1
Defense and Veterans Pain Scale
Using the Defense and Veterans Pain Scale, patients will rate their pain ranging from 0 (no pain) to 10 (severe pain)
Time frame
2 weeks after TKA procedure2
Opioid-Related Symptom Distress Scale (ORSDS)
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
Time frame
At baseline and 2 weeks after TKA procedure3
Pittsburgh Sleep Quality Index
Patients will complete survey to monitor sleeping habits
Time frame
At baseline and 2 weeks after TKA procedure4
Total opioid usage over 2 weeks post-operatively
Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption.
Time frame
2 weeks after TKA procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov