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

ACL Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401450
• Other study ID #: 17-01602
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: June 29, 2021

Study information

• Verified date: June 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 29, 2021
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACL Surgery

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents	Amount of morphine equivalents administered intraoperatively in 24 hours	24 Hours
Primary	Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents	Amount of morphine equivalents administered postoperatively in 24 hours	24 Hours
Primary	Side Effects Such as Nausea, Itching, Constipation.		24 hours
Secondary	Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months.		12 months