Phase 4
N=82
iPACK for Post-op Pain Following ACL Reconstruction
ACL Injury · Post Operative Pain
Bottom Line
View on ClinicalTrials.gov: NCT05498870 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Pain Scores — 41.5; 29.8; 37.9; 47.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Adductor Canal Block (ACB) Only (Drug); Adductor Canal Block (ACB) + iPACK Block (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores |
41.5; 29.8; 37.9; 47.4; 38.7; 49.9 | — |
| SECONDARY Total Postoperative Opioid Consumption (Total MME) |
8.26; 11.2; 6.09; 10.5; 10.4; 16.2 | — |
| SECONDARY Range of Motion (Degrees) |
90.0; 99.3 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT05498870). 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.