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

Study Overview

• Status: Completed
• Conditions: ACL Surgery
• Intervention / Treatment: Drug: ACB within true AC with bupivacaine 0.5% 20cc; Drug: ACB proximal to true AC with bupivacaine 0.5% 20cc

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: ACB within true AC with bupivacaine 0.5% 20cc; 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
Active Comparator: 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	Drug: ACB proximal to true AC with bupivacaine 0.5% 20cc; Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine; Other Names: bupivacaine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Prianka Desai, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): January 25, 2019
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 17-01602

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No