Methadone in TKA for Post-op Pain and Opioid Reduction

Phase 3RecruitingNCT07226076

Medical University of South Carolina162 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

162

Conditions

Post Operative Pain

Interventions

Methadone HydrochlorideDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Patient reported pain in the recovery unit after surgery

Patient reported pain on a Visual Analog Scale (VAS) from 0-100mm at approximately 30-60 minutes after arriving to the recovery unit after surgery. A lower pain score means a better outcome.

Time frame: up to 24 hours after surgery ends

Secondary Outcomes

Opioid Consumption in the recovery unit

Opioid consumption measured in oral morphine milligram equivalents (MMEs) while the patient is in the PACU (Post-Anesthesia Recovery Unit).

Time frame: PACU Arrival until PACU Discharge up to 30 days

Time to first opioid rescue dose

Measured from the PACU arrival time, to the time the first opioid rescue dose is given while in the PACU.

Time frame: up to 24 hours after surgery ends

Pain scores

Visual Analog Score (VAS) 0-100mm reporting pain at rest, and with movement. A lower pain score means a better outcome.

Time frame: PACU, 24 hours, 48 hours, and 72 hours post-operatively.

Postoperative nausea and/or vomiting

Incidence of postoperative nausea and/or vomiting after surgery as reported by the patient.

Time frame: PACU through 72 hours post-operatively

Quality of Recovery

Change in quality of recovery score from baseline to 24-hours post-operatively measured using the Quality of Recovery 15 Assessment (QoR-15). This assessment is scored 0-150, with a higher score indicating a better quality of recovery. Each of the 15 questions is on an 11-point numerical rating scale from 0-10, and the selections are added together to result in the total score.

Time frame: up to 24-hours post-operatively

Central Contacts

Haley Nitchie, MHA

CONTACT

843-792-1869 nitchie@musc.edu

Data from ClinicalTrials.gov

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