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Clinical Trials/NCT03401450
NCT03401450
Completed
Phase 4

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

NYU Langone Health1 site in 1 country69 target enrollmentFebruary 1, 2018

Overview

Phase
Phase 4
Intervention
ACB within true AC with bupivacaine 0.5% 20cc
Conditions
ACL Surgery
Sponsor
NYU Langone Health
Enrollment
69
Locations
1
Primary Endpoint
Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
June 29, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

ACB within true AC with bupivacaine

The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine

Intervention: ACB within true AC with bupivacaine 0.5% 20cc

ACB proximal to true AC with bupivacaine

The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine

Intervention: ACB proximal to true AC with bupivacaine 0.5% 20cc

Outcomes

Primary Outcomes

Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents

Time Frame: 24 Hours

Amount of morphine equivalents administered intraoperatively in 24 hours

Side Effects Such as Nausea, Itching, Constipation.

Time Frame: 24 hours

Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents

Time Frame: 24 Hours

Amount of morphine equivalents administered postoperatively in 24 hours

Secondary Outcomes

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

Study Sites (1)

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