Phase 4
N=102
Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft:
Anterior Cruciate Ligament Rupture
Bottom Line
View on ClinicalTrials.gov: NCT05286307 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Opioid Utilization in First 24 Hours Post-Surgery — 6.1; 10.7 morphine milligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IPACK block (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Utilization in First 24 Hours Post-Surgery |
6.1; 10.7 | — |
| SECONDARY Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery |
55.2; 67.7 | — |
| SECONDARY Patient-Reported VAS Scores at 48 Hours Post-Surgery |
55.5; 64 | — |
| SECONDARY Patient-Reported VAS Scores at 72 Hours Post-Surgery |
44.4; 54.9 | — |
| SECONDARY Patient-Reported VAS Scores at Day 7 Post-Surgery |
36.3; 42 | — |
| SECONDARY Length of Stay in Post-Anesthesia Care Unit (PACU) |
131.19; 131.22 | — |
| SECONDARY Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS) |
4.88; 13.52 | — |
| SECONDARY Change in Kujala Scale Score |
9.47; 18.75 | — |
| SECONDARY Change in Tegner Activity Scale (TAS) Score |
1.25; 1.92 | — |
| SECONDARY Change of Range of Motion (ROM) Assessment |
— | — |
Summary
A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft
Eligibility Criteria
Inclusion Criteria
- Patients between 18 and 75 years of age
- Patients undergoing primary ACL reconstruction with BPTB Autograft
- ASA I or II
Exclusion Criteria
- Patients younger than 18 and older than 75.
- Patients with multi-ligament injury
- Patients undergoing concomitant cartilage procedure or osteotomy.
- Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer.
- Patients who are allergic to oxycodone;
- Patients with diagnosed or self-reported cognitive dysfunction;
- Patients with a history of neurologic disorder that can interfere with pain sensation;
- Patients with a history of drug or recorded alcohol abuse;
- Patients who are unable to understand or follow instructions;
- Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
- Patients with a BMI over 45;
- Any patient that the investigators feel cannot comply with all study related procedures;
- Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;
Data sourced from ClinicalTrials.gov (NCT05286307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.