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OpenTrials
Completed

NCT Number: NCT03292926

A Novel Analgesia Technique for ACL Reconstruction

A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

13 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10023, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing BTB ACL reconstruction with participating surgeon
  • Age 13 or greater
  • Planned use of regional anesthesia
  • Ability to follow study protocol
  • English speaking (secondary outcomes include questionnaires validated in English only)

Exclusion criteria

  • Hepatic or renal insufficiency
  • Younger than 13 years old
  • Patients undergoing general anesthesia
  • Allergy or intolerance to one of the study medications
  • BMI > 40
  • Diabetes
  • American Society of Anesthesiology (ASA) score IV
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of >5mg/day for one month)
  • Non-English speaking

Treatment and study plan

Bupivacaine

Drug

Bupivacaine will help treat pain and sensation after ACL repair

Ultrasound

Device

Ultrasound will guide anesthesiologist in performing the different nerve blocks

Dexamethasone

Drug

Dexamethasone will be used to prolong block duration

Other names: preservative free Dexamethasone

Primary outcomes

  1. Pain While at Rest

    Time frame: 24 hours post-block administration

    Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.

Secondary outcomes

  1. Discharge Criteria

    Time frame: From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day

    Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.

  2. Pain With Ambulation

    Time frame: 3 hours post-block administration on Post-operative day (POD) 0

    NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2017
Registry last updated
Sep 19, 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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