drugset / Trial / NCT05316168

Post Operative Pain Management for ACL Reconstruction

NCT05316168 ↗

Phase 3 Unknown 154 enrolled Rothman Institute Orthopaedics
RandomizedParallel-groupDouble-blindPrevention

Summary

Health care providers are seeking methods to limit post-operative pain and opioid prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block (ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery. Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR) patients who received isolated ACB versus ACB with IPACK. The primary aim of this study is to investigate the role of IPACK in combination with ACB in reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim is to determine any effect of IPACK on post-operative functional outcomes.

Timeline

Start
2023-09-30
Primary completion
2024-09-30
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine HCl 0.5% Injectable Solution Unknown 0.5 % —
Comparator Bupivacaine HCl 0.5% Injectable Solution Unknown 20 ml —
Comparator Dexamethasone Small molecule 2 mg —
Comparator Percocet 5Mg-325Mg Tablet Unknown 5 mg —
Comparator Percocet 5Mg-325Mg Tablet Unknown 325 mg —

Indications

No indication recorded.