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Clinical Trials/NCT05004506
NCT05004506
Unknown
Phase 3

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

Loyola University1 site in 1 country100 target enrollmentApril 20, 2016

Overview

Phase
Phase 3
Intervention
Adductor Canal Block
Conditions
Post-Operative Pain, Chronic
Sponsor
Loyola University
Enrollment
100
Locations
1
Primary Endpoint
Analgesic efficacy
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2016
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Loyola University
Responsible Party
Sponsor

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

Arms & Interventions

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.

Intervention: Adductor Canal Block

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.

Intervention: Intra-articular Injection

Outcomes

Primary Outcomes

Analgesic efficacy

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

VAS pain scores

Rescue narcotics use

Time Frame: During post-surgical hospitalization

Opioid requirement due to pain

Total narcotic consumption

Time Frame: During post-surgical hospitalization

Opioid requirement overall

Study Sites (1)

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