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

Phase 4

Completed

• Conditions: ACL Surgery
• Interventions: Drug: ACB proximal to true AC with bupivacaine 0.5% 20cc; Drug: ACB within true AC with bupivacaine 0.5% 20cc

• Registration Number: NCT03401450
• Lead Sponsor: NYU Langone Health

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-17
• Study Start: 2018-02-01
• Primary Completion: 2019-01-25
• Results First Submitted: 2020-12-01
• Results First Submitted QC: 2020-12-22
• Results First Posted: 2020-12-23
• Study Completion: 2021-06-29
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACB proximal to true AC with bupivacaine	ACB proximal to true AC with bupivacaine 0.5% 20cc	The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine
ACB within true AC with bupivacaine	ACB within true AC with bupivacaine 0.5% 20cc	The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine

Primary Outcome Measures

Name	Time	Method
Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents	24 Hours	Amount of morphine equivalents administered intraoperatively in 24 hours
Side Effects Such as Nausea, Itching, Constipation.	24 hours
Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents	24 Hours	Amount of morphine equivalents administered postoperatively in 24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States