Methadone in TKA for Post-op Pain and Opioid Reduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-08

Study Completion Date

2027-01-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Methadone

Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.

Group Type ACTIVE_COMPARATOR

Methadone Hydrochloride

Intervention Type DRUG

Patients will intraoperatively be administered methadone 0.15mg/kg IV, based on ideal body weight.

No Methadone

Patients will NOT receive methadone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Methadone Hydrochloride

Patients will intraoperatively be administered methadone 0.15mg/kg IV, based on ideal body weight.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No