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

Sponsor

Loyola University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05004506

Collaborator

(none)

100

Enrollment

Location

Arms

80.4

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Operative Pain, Chronic	Drug: Adductor Canal Block Drug: Intra-articular Injection	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Prospective Randomized Controlled Trial of Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery

Study Start Date :

Apr 20, 2016

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	Drug: Intra-articular Injection receive 20ccs of 2% lidocaine with epinephrine as an intra-articular injection

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Active Comparator: 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.

Drug: Intra-articular Injection

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

Outcome Measures

Primary Outcome Measures

Analgesic efficacy [1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery]
VAS pain scores
Rescue narcotics use [During post-surgical hospitalization]
Opioid requirement due to pain
Total narcotic consumption [During post-surgical hospitalization]
Opioid requirement overall

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loyola University Medical Center	Maywood	Illinois	United States	60153

Sponsors and Collaborators

Loyola University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Loyola University

ClinicalTrials.gov Identifier:

NCT05004506

Other Study ID Numbers:

LU208664

First Posted:

Aug 13, 2021

Last Update Posted:

Apr 12, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Pain, Postoperative

Chronic Pain

Study Results

No Results Posted as of Apr 12, 2022