iPACK for Post-op Pain Following ACL Reconstruction
- Conditions
- ACL InjuryPost Operative Pain
- Interventions
- Drug: Adductor Canal Block (ACB) OnlyDrug: Adductor Canal Block (ACB) + iPACK Block
- Registration Number
- NCT05498870
- Lead Sponsor
- Medical University of South Carolina
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- Age 12 years and older
- Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adductor Canal Block (ACB) Only Adductor Canal Block (ACB) Only Participants randomized to the ACB only group will receive an adductor canal block alone. ACB + iPACK Adductor Canal Block (ACB) + iPACK Block Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
- Primary Outcome Measures
Name Time Method Pain Scores 0-72 hours post op The primary endpoint will measure subjective pain scores using a Visual Analog Scale ranging from 0 (no pain) to 100 (severe intolerable pain) at 12-hour intervals during the first 72 hours of the postoperative window. A higher score means worse outcome.
- Secondary Outcome Measures
Name Time Method Total Postoperative Opioid Consumption (Total MME) up to 72 hours post-op The secondary endpoints will measure perioperative opioid consumption through postoperative day 2 in 12-hour intervals and converted into morphine milligram equivalents using standard conversions.
Range of Motion (Degrees) up to two months after surgery An additional secondary endpoint is the range of motion, measured in degrees, of the operative knee at post-op visit 1 and 2. The post-op measurements will be compared to the pre-operative measurements. The scale of range of motion is from 0 - 135 degrees. The higher the score (degrees), the better the outcome.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States