Methadone in TKA for Post-op Pain and Opioid Reduction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methadone Hydrochloride.
- Who it may be relevant to
- Registry conditions: Post Operative Pain. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Knee Arthroplasty: a Double-blind Randomized Control Trial
Overview
This randomized, double-blind controlled trial investigates whether intraoperative IV methadone (0.15 mg/kg based on ideal body weight) reduces acute postoperative pain and opioid consumption in patients undergoing elective total knee arthroplasty under spinal anesthesia with mepivacaine.
Interventions
- Drug Methadone Hydrochloride
Patients will intraoperatively be administered methadone 0.15mg/kg IV, based on ideal body weight.
Primary outcome measures
- Patient reported pain in the recovery unit after surgery [Time frame: up to 24 hours after surgery ends]
Secondary outcome measures (5)
- Opioid Consumption in the recovery unit [Time frame: PACU Arrival until PACU Discharge up to 30 days]
- Time to first opioid rescue dose [Time frame: up to 24 hours after surgery ends]
- Pain scores [Time frame: PACU, 24 hours, 48 hours, and 72 hours post-operatively.]
- Postoperative nausea and/or vomiting [Time frame: PACU through 72 hours post-operatively]
- Quality of Recovery [Time frame: up to 24-hours post-operatively]
Eligibility criteria
Inclusion
- Ages 18-75 years of age
- Undergoing elective primary total knee arthroplasty with mepivacaine in the spinal anesthesia
Exclusion
- Allergy to methadone or mepivacaine
- Severe liver disease defined as Child's Pugh Class C
- End stage renal disease requiring dialysis
- Known diagnosis of prolonged QT syndrome
- Currently pregnant
- Unable to provide written, informed consent
- Non-English speaking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT07226076 · Pro00147447