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Recruiting NCT07227064

Methadone in THA for Post-op Pain and Opioid Reduction

Phase III Interventional Post Operative Pain Total Hip Arthroplasty

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.
Who it may be relevant to
Registry conditions: Post Operative Pain, Total Hip Arthroplasty. 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 →

Unsure about the terms? Read our patient guide →

Official title

Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Hip Arthroplasty: a Double-blind Randomized Control Trial

Overview

This randomized, double-blind controlled trial investigates whether intraoperative intravenous methadone (0.15 mg/kg based on ideal body weight) reduces acute postoperative pain and opioid consumption in patients undergoing elective total hip arthroplasty under spinal anesthesia with mepivacaine. The primary outcome is patient-reported pain on a visual analog scale (VAS) 30-60 minutes after arrival in the post-anesthesia care unit (PACU). Secondary outcomes include opioid use, pain scores over time, incidence of nausea/vomiting, and quality of recovery. A total of 162 subjects will be enrolled at MUSC surgical sites.

Interventions

  • Drug Methadone
    Patients will intraoperatively receive 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 hip 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: NCT07227064 · Pro00147100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗