Post Operative Pain, Total Hip Arthroplasty
Conditions
Brief summary
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
DRUGMethadone
Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported pain in the recovery unit after surgery | up to 24 hours after surgery ends | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 hip 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 in a yes/no questionnaire format. |
| 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. |
Countries
United States
Contacts
CONTACTHaley Nitchie, MHA
PRINCIPAL_INVESTIGATORChristopher Fatora, MD
Medical University of South Carolina
Outcome results
None listed