Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery

NCT05004506 | Unknown Phase 3 FDA Drug

• 1 other identifier: LU208664
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized study that compares two commonly used post-operative pain reducing techniques by measuring the level of pain and use of pain medication after knee surgery.

Conditions

Post-Operative Pain, Chronic

Outcome Measures

Primary Outcomes (3)

• Analgesic efficacy

  VAS pain scores

  1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery

• Rescue narcotics use

  Opioid requirement due to pain

  During post-surgical hospitalization

• Total narcotic consumption

  Opioid requirement overall

  During post-surgical hospitalization

Study Arms (2)

Group A

EXPERIMENTAL

Group A patients will receive their treatment at the completion of the case while under general anesthesia. The anesthesia provider will identify the adductor canal using ultrasound guidance and inject 15ccs of 0.5% marcaine with epinephrine around the saphenous nerve. Group A patients will receive placebo intra-articular and arthroscopic portal site saline injections equal in volume and procedure time point as the treatment in Group B. At the completion of the case, the patient will be extubated and transferred to the PACU.

Drug: Adductor Canal Block

Group B

ACTIVE COMPARATOR

Group B will receive 20ccs of 2% lidocaine with epinephrine as an intra-articular injection. At the completion of the arthroscopic procedure the patient will receive an additional 20ccs of 0.5% marcaine with epinephrine intra-articular injection. Group B patients will also receive 10ccs of 2% lidocaine with epinephrine injected superficially into each of the arthroscopic portal sites. Group B patients will receive a 15cc saline injection around the saphenous nerve under the same procedure as the adductor canal block for Group A. At the completion of the case, the patient will be extubated and transferred to the PACU.

Drug: Intra-articular Injection

Interventions

Adductor Canal Block DRUG

The anesthesia provider will identify the adductor canal using ultrasound guidance and inject 15ccs of 0.5% marcaine with epinephrine around the saphenous nerve.

Group A

Intra-articular Injection DRUG

receive 20ccs of 2% lidocaine with epinephrine as an intra-articular injection

Group B

Eligibility Criteria

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

You may qualify if:

• ASA I-III patients
• Age 18 to 65 years

You may not qualify if:

• Allergy or intolerance to local anesthetics, NSAIDs, or opioids
• Inability to understand the consent or study process
• Any contraindication to regional anesthesia
• Known history of substance abuse
• Chronic home opioid therapy
• History of major neurologic deficit in operative limb
• Chronic pain syndromes
• Pregnancy and nursing women

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A will be for single shot adductor canal block. Group B will receive the intra-articular injection.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 13, 2021
• Study Start: April 20, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)