Post Operative Pain
Conditions
Keywords
post-operative pain
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.
Interventions
Patients will intraoperatively be administered 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 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
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 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 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. |
Countries
United States
Contacts
CONTACTHaley Nitchie, MHA
PRINCIPAL_INVESTIGATORWilliam Barrett, M.D.
Medical University of South Carolina
Outcome results
None listed