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Completed

NCT Number: NCT05498870

iPACK for Post-op Pain Following ACL Reconstruction

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.

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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adductor Canal Block (ACB) Only

Drug

Patients will receive an ACB with lidocaine skin wheal

Adductor Canal Block (ACB) + iPACK Block

Drug

Patients will receive an ACB with iPACK block

Primary outcomes

  1. Pain Scores

    Time frame: 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 outcomes

  1. Total Postoperative Opioid Consumption (Total MME)

    Time frame: 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.

  2. Range of Motion (Degrees)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2022
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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