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

NCT03401450 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-01602
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Conditions

ACL Surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  12 months

Study Arms (2)

ACB within true AC with bupivacaine

ACTIVE COMPARATOR

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

ACB proximal to true AC with bupivacaine

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: bupivacaine

ACB within true AC with 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

Also known as: bupivacaine

ACB proximal to true AC with bupivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Prianka Desai
• Organization: NYU Langone

prianka.desai@nyulangone.org

212-263-5072

Study Officials

• Prianka Desai, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 17, 2018
• Study Start: February 1, 2018
• Primary Completion: January 25, 2019
• Study Completion: June 29, 2021
• Last Updated: July 14, 2023
• Results First Posted: December 23, 2020

Record last verified: 2023-06

Locations

US (1)