Methadone in THA for Post-op Pain and Opioid Reduction
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-75 years of age
Undergoing elective primary total hip arthroplasty with mepivacaine in the spinal anesthesia
Allergy to methadone or mepivacaine
Severe liver disease defined as Child's Pugh Class C
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Methadone
DrugPatients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.
Treatment groups
162 Participants
are divided into 2 treatment groupsGroup A: MethadoneActive comparator 1 intervention
Group B: No MethadoneNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Patient reported pain in the recovery unit after surgery
Patient reported hip 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 endsSecondary outcomes
1
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 days2
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 ends3
Pain scores
Visual Analog Score (VAS) 0-100mm reporting hip 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.4
Postoperative nausea and/or vomiting
Incidence of postoperative nausea and/or vomiting after surgery as reported by the patient in a yes/no questionnaire format.
Time frame
PACU through 72 hours post-operativelySponsors and contacts
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Source ClinicalTrials.gov