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A Pilot Randomized Controlled Trial Assessing the Impact of Dexmedetomidine as an Adjunct to Periarticular Ropivacaine Infiltration on Postoperative Pain and Recovery in Patients Undergoing Total Knee Replacement
This study aims to evaluate whether adding dexmedetomidine to ropivacaine-based periarticular infiltration (PAI) improves postoperative pain control in patients undergoing total knee replacement (TKR). Despite standard pain management, many patients continue to experience moderate-to-severe pain after surgery. Dexmedetomidine, a sedative and analgesic agent, may help prolong the effect of local anaesthetics. A total of 60 patients will be randomly assigned to receive either ropivacaine alone or ropivacaine with dexmedetomidine. Pain scores, opioid use, side effects, and recovery time will be monitored for 24 hours. The goal is to determine if this method is more effective and safer for improving recovery after knee surgery.
Details
| Lead sponsor | University of Malaya |
|---|---|
| Phase | Phase 4 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 60 |
| Start date | 2025-10 |
| Completion | 2028-12 |
Conditions
- Postoperative Pain Management in Total Knee Arthroplasty
Interventions
- Ropivacaine + saline solution
- Ropivacaine + Dexmedetomidine
Primary outcomes
- 24-hour postoperative pain score (NRS 0-10) at rest and during movement — 24 hours postoperatively (from time of skin closure)
Pain intensity will be assessed using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain. Measurements will be taken at rest and during passive knee flexion to 90°, at 1, 6, 12, and 24 hours postoperatively. The primary endpoint is the NRS score at 24 hours.
Countries
Malaysia