Clinical trial

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

Name
ftjo21D.1099
Description
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.
Trial arms
Trial start
2023-09-30
Estimated PCD
2024-09-30
Trial end
2024-09-30
Phase
Early phase I
Treatment
Bupivacaine HCl 0.5% Injectable Solution
During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5%
Arms:
isolated adductor canal block (ACB), isolated adductor canal block (ACB) + IPACK
Dexamethasone
During adductor canal block participants will receive 2mg Dexamethasone
Arms:
isolated adductor canal block (ACB), isolated adductor canal block (ACB) + IPACK
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
Arms:
isolated adductor canal block (ACB) + IPACK
Percocet 5Mg-325Mg Tablet
Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control
Arms:
isolated adductor canal block (ACB), isolated adductor canal block (ACB) + IPACK
Size
154
Primary endpoint
Post operative pain management
14 days
Post operative pain management 2
6 months
Eligibility criteria
Inclusion Criteria: * All patients undergoing primary ACLR for ACL tear, including patients with concomitant meniscectomy or meniscal repair. Exclusion Criteria: * Revision ACLR, worker's compensation, pregnancy, age\<18 years
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 154, 'type': 'ESTIMATED'}}
Updated at
2023-09-21

1 organization

3 products

2 indications

Indication
Pain
Indication
Postoperative
Product
Percocet