drugset / Trial / NCT06630520
Intraoperative Periarticular Injection in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2022-03-20
- Primary completion
- 2022-06-20
- Completion
- 2023-06-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 150 mg | Other |
| Subject | Ketorolac | Other / unclassified | 60 mg | Other |
| Subject | Morphine | Other / unclassified | 1 mg | Other |
| Background | Acetaminophen | Small molecule | 500 mg | Oral |
| Background | Diclofenac | Other / unclassified | 75 mg | Oral |
Indications
No indication recorded.