Clinical trial

Studying the Effects of iPACK Blocks With Adductor Canal Blocks for Postoperative Analgesia Following ACL Reconstruction

Name
Pro00121103
Description
This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.
Trial arms
Trial start
2022-07-27
Estimated PCD
2023-07-03
Trial end
2023-08-14
Status
Completed
Phase
Early phase I
Treatment
Adductor Canal Block (ACB) Only
Patients will receive an ACB with lidocaine skin wheal
Arms:
Adductor Canal Block (ACB) Only
Adductor Canal Block (ACB) + iPACK Block
Patients will receive an ACB with iPACK block
Arms:
ACB + iPACK
Size
82
Primary endpoint
Pain Scores
0-72 hours post op
Eligibility criteria
Inclusion Criteria: * Age 12 years and older * Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft. Exclusion Criteria: * Any contraindication to receiving regional anesthesia. This may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury. * Patients undergoing hamstring graft or allograft for ACL * Pre-existing infection at the site of injury * Patients on chronic opioid treatments * Pre-existing sensory or motor deficit in operative extremity * Patients having a revision of previous ACL reconstruction * Pregnant and/or lactating women * Weighs less than 40kg
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Only the patient will be blinded to the treatment group.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 82, 'type': 'ACTUAL'}}
Updated at
2023-10-03

1 organization

2 products

2 indications