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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone | Active Comparator | Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight. |
|
| No Methadone | No Intervention | Patients will NOT receive methadone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 24 hours after surgery ends |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | PACU Arrival until PACU Discharge up to 30 days |
| Time to first opioid rescue dose |
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Inclusion
Exclusion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haley Nitchie, MHA | Contact | 843-792-1869 | nitchie@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Fatora, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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Measured from the PACU arrival time, to the time the first opioid rescue dose is given while in the PACU. |
| up to 24 hours after surgery ends |
| Pain scores | Visual Analog Score (VAS) 0-100mm reporting hip pain at rest, and with movement. A lower pain score means a better outcome. | PACU, 24 hours, 48 hours, and 72 hours post-operatively. |
| 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. | PACU through 72 hours post-operatively |
| Quality of Recovery | 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. | up to 24-hours post-operatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |