Methadone in TKA for Post-op Pain and Opioid Reduction

Not Applicable

Not yet recruiting

• Conditions: Post Operative Pain
• Interventions: Drug: Methadone Hydrochloride

• Registration Number: NCT07226076
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-06
• Study First Submitted QC: 2025-11-06
• Study First Posted: 2025-11-07
• Last Update Submitted: 2025-11-07
• Last Update Posted: 2025-11-12
• Study Start: 2025-11-28
• Primary Completion: 2026-11-28
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methadone	Methadone Hydrochloride	Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.

Primary Outcome Measures

Name	Time	Method
Patient reported pain in the recovery unit after surgery	up to 24 hours after surgery ends	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.

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption in the recovery unit	PACU Arrival until PACU Discharge up to 30 days	Opioid consumption measured in oral morphine milligram equivalents (MMEs) while the patient is in the PACU (Post-Anesthesia Recovery Unit).
Time to first opioid rescue dose	up to 24 hours after surgery ends	Measured from the PACU arrival time, to the time the first opioid rescue dose is given while in the PACU.
Pain scores	PACU, 24 hours, 48 hours, and 72 hours post-operatively.	Visual Analog Score (VAS) 0-100mm reporting pain at rest, and with movement. A lower pain score means a better outcome.
Postoperative nausea and/or vomiting	PACU through 72 hours post-operatively	Incidence of postoperative nausea and/or vomiting after surgery as reported by the patient.
Quality of Recovery	up to 24-hours post-operatively	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.