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The concern for the opioid use in the total knee arthroplasty continues to rise in recent decades. Historically, the total knee arthroplasty consumed high doses opioids in the postoperative periods. Compared to the Opioid-Based patient controlled analgesia(PCA), the opioid-sparing protocol may have benefits to decrease the concerns of the opioid use and opioid-related complication and provides the equivalent efficacy for pain control. The purpose of this trial in to provide a novel opioid-sparing protocol (OSP) to evaluate the efficacy for pain control and reducing the immediate postoperative opioid consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Sparing Protocol | Experimental | Preemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. |
|
| Opioid Based Patient Controlled Analgesia | Active Comparator | Preemptive(before incision) and Postoperative: the initial setting was 0.01mg/kg*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours; adjusted by the PCA staff |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid-Sparing Protocol | Drug | After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. In the opioid-sparing group, a dose of Parecoxib sodium 40 mg was administrated through intravenous route before the incision. After the surgery, Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores using numerical rating scale (VAS, 0 to 10) at rest | Post-operative 6 hours | Post-operative 6 hours after surgery |
| Pain scores using numerical rating scale (VAS, 0 to 10) at rest | Post-operative 12 hours | Post-operative 12 hours after surgery |
| Pain scores using numerical rating scale (VAS, 0 to 10) at rest | Post-operative 24 hours | Post-operative 24 hours after surgery |
| Pain scores using numerical rating scale (VAS, 0 to 10) at rest | Post-operative 48 hours | Post-operative 48 hours after surgery |
| Pain scores using numerical rating scale (VAS, 0 to 10) at rest | Post-operative 72 hours | Post-operative 72 hours after surgery |
| Pain scores using numerical rating scale (VAS, 0 to 10) at motion | Post-operative 24 hours | Post-operative 24 hours after surgery |
| Pain scores using numerical rating scale (VAS, 0 to 10) at motion | Post-operative 48 hours | Post-operative 48 hour hours after surgery |
| Pain scores using numerical rating scale (VAS, 0 to 10) at motion |
| Measure | Description | Time Frame |
|---|---|---|
| maximum angle of continuous passive motion (CPM) as tolerated (Degrees) | recorded at post-operative 24 hours, 48 hours and 72 hours | 0-72 hours after surgery |
| Cumulative morphine consumption(mg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsuan-Hsiao Ma, M.D. | Contact | 02-28717557 | tyc20192@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shang-Wen Tsai, M.D. | Department of Orthopaedic and Traumatology, Taipei Veterans General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital | Recruiting | Taipei City | Taipei | 112 | Taiwan |
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| Opioid-Based Patient Controlled Analgesia | Drug | After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. The patient was informed that the intravenous bolus of rescue morphine (4mg) was available every 4 hours if the pain was intolerable. In the PCA group, the device was applied before incision and the initial setting was 0.01mg/kg*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours. After the surgery, the staff of PCA group would visit the patients and adjusted the dosage. The PCA was removed after 72 hours from the surgery. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery. |
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Post-operative 72 hours
| Post-operative 72 hour hours after surgery |
recorded at post-operative 24 hours, 48 hours and 72 hours
| 0-72 hours after surgery |
| drug-related (opioid) adverse events | nausea/vomiting, dizziness, urinary retention, pruritus, dry mouth, constipation, dyspepsia, GI bleeding, pitting edema over lower extremities, cardiovascular event, respiratory depression, delirium or coma | 0-72 hours after surgery |
| Satisfaction scale (0-100 points) | satisfaction with regard to the efficacy and safety of the pain management protocol. | postoperative 2 weeks after surgery |
| Length of hospital stay (LOS) (Days) | Time from admission to discharge | After surgery until discharge (about 3-5 days after surgery) |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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