MedPath

iPACK for Post-op Pain Following ACL Reconstruction

Phase 4
Completed
Conditions
ACL Injury
Post Operative Pain
Interventions
Drug: Adductor Canal Block (ACB) Only
Drug: 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Adductor Canal Block (ACB) OnlyAdductor Canal Block (ACB) OnlyParticipants randomized to the ACB only group will receive an adductor canal block alone.
ACB + iPACKAdductor Canal Block (ACB) + iPACK BlockParticipants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
Primary Outcome Measures
NameTimeMethod
Pain Scores0-72 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
NameTimeMethod
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

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