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

NCT ID: NCT05004506

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-20
• Study Completion Date: 2022-12-31

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.

Detailed Description

Post-operative pain is a commonly associated with knee surgery. Treatment often includes an oral or intravenous (IV) narcotic regimen which often leads to nausea, vomiting and can cause consti-pation. These issues can contribute to the overall discomfort of the post-operative patient. Intra-operative injections and local nerve blocks have become common adjuncts to narcotics to reduce post-operative pain and the necessity for oral or IV narcotic use. The aim of this study is to com-pare analgesic use and clinical effects on post-operative pain management with intra-articular in-jection of 20ccs of 2% lidocaine with epinephrine at the start of the case plus 20ccs 0.5% mar-caine with epinephrine at the end of the case vs. adductor canal saphenous nerve blockade in pa-tients undergoing knee arthroscopy, as indicated by the need for rescue narcotics and patient pain scores. A randomized, single blinded study will be performed to evaluate post-operative pain control using VAS scores at 1, 2, 4, 8, 12, 24, 36, and 48hrs post-operatively, rescue narcotic use in the PACU, and total narcotic consumption over the same time period.

Conditions

Post-Operative Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

Adductor Canal Block

Intervention Type: 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 B

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.

Group Type: ACTIVE_COMPARATOR

Intra-articular Injection

Intervention Type: DRUG

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

Interventions

Adductor Canal Block

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

Intervention Type: DRUG

Intra-articular Injection

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

Other Identifiers

LU208664

Identifier Type: -

Identifier Source: org_study_id