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In this prospective, assessor-blinded, single-surgeon clinical trial, the goal was to validate the efficacy of PAI in aACLR surgery with a reduced opioid dose, while achieving similar pain relief with few adverse events. 300 patients who had undergone aACLR were randomly allocated to receive either a PAI or nPAI group. The primary outcome parameters were visual analogue scale (VAS) scores and cumulative morphine dose, through time. Secondary outcome parameters included drug-related adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periarticular injection | Active Comparator |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periarticular injection | Combination Product | A 50ml periarticular injection was introduced intraoperatively before the time of closing. The injection contained 150mg bupivacaine (3mg/mL), 60mg ketorolac(1.2mg/mL) and 1mg morphine. Before wound closure, periarticular cocktail was injected around the knee joint including the adductor canal from the hamstring harvest side in PAI group. All patients had oral paracetamol 500mg, 4 times/day and diclofenac 75mg, 1 times/day after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS scores | at different time points (postoperative 4,8,24-hour, before discharge) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative morphine consumption (mg) | at post-operative 4, 8, 24-hour and before discharge |
| Measure | Description | Time Frame |
|---|---|---|
| drug related adverse events | within postoperative 2 weeks | |
| overall satisfaction scale (0-100 points) | at postoperative 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan | 112 | Taiwan |
Concerning the patient's privacy
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|
| ID | Term |
|---|---|
| D022125 | Lacerations |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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