NCT05316168

Post Operative Pain Management for ACL Reconstruction

Isolated Adductor Canal Block vs Adductor Canal Block With IPACK in ACL Reconstruction: A Randomized, Prospective Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Bupivacaine HCl 0.5% Injectable Solution	During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5%
DRUG	Dexamethasone	During adductor canal block participants will receive 2mg Dexamethasone
PROCEDURE	Infiltration between Popliteal Artery and Capsule of the knee (iPACK)	Prior to closing the surgical wound participants will receive a local injections of 20cc 0.5% bupivacaine mixed with 2mg dexamethasone
DRUG	Percocet 5Mg-325Mg Tablet	Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control

Timeline

• Start date: 2023-09-30
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2022-04-07
• Last updated: 2023-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study