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OpenTrials
Completed

NCT Number: NCT03401450

Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block

This is a prospective, randomized, single blinded trial involving human subjects. The goal of this study is to determine an optimal location (proximal or distal) for the nerve block and whether it will make a difference in how much opioid the patient will receive during and after surgery. Ultrasound will identify the adductor canal and the proximal end of the adductor canal/apex of the femoral triangle to determine the location of the blocks.

Their will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB proximal to true AC with bupivacaine 0.5% 20cc

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Key information

Conditions

ACL Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing unilateral, ACL surgery with allograft.
  • Patients who consent to be randomized.
  • Patients must be English proficient.

Exclusion criteria

  • Patients younger than 18 or older than 75 years of age;
  • Patients with a history of chronic pain or who are taking medications intended to treat chronic pain such as strong opioids;
  • Patients with history of neurologic disorder that can interfere with pain sensation;
  • Patients with a history of drug or alcohol abuse;
  • Patients who are unable to understand or follow instructions;
  • Patients with an allergy or a contraindication to any of the medications used in the study, or patients with a contraindication to any of the study procedures;
  • Patients with severe liver disease, renal insufficiency, congestive heart failure, and/ or significant heart disease;
  • Patients with a BMI over 42;
  • Any patient that the investigators feel cannot comply with all study related procedures.
  • Patients who do not tolerate Percocet.

Treatment and study plan

ACB within true AC with bupivacaine 0.5% 20cc

Drug

The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.

Other names: bupivacaine

ACB proximal to true AC with bupivacaine 0.5% 20cc

Drug

Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine

Other names: bupivacaine

Primary outcomes

  1. Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents

    Time frame: 24 Hours

    Amount of morphine equivalents administered intraoperatively in 24 hours

  2. Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents

    Time frame: 24 Hours

    Amount of morphine equivalents administered postoperatively in 24 hours

  3. Side Effects Such as Nausea, Itching, Constipation.

    Time frame: 24 hours

Secondary outcomes

  1. Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Jan 17, 2018
Registry last updated
Jul 14, 2023

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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