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

Primary Purpose

Post-Operative Pain, Chronic

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Adductor Canal Block
Intra-articular Injection
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Operative Pain, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Analgesic efficacy
VAS pain scores
Rescue narcotics use
Opioid requirement due to pain
Total narcotic consumption
Opioid requirement overall

Secondary Outcome Measures

Full Information

First Posted
August 11, 2021
Last Updated
April 11, 2022
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT05004506
Brief Title
Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery
Official Title
A Prospective Randomized Controlled Trial of Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2016 (undefined)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Group A will be for single shot adductor canal block. Group B will receive the intra-articular injection.
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Adductor Canal Block
Intervention Description
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
Intervention Name(s)
Intra-articular Injection
Intervention Description
receive 20ccs of 2% lidocaine with epinephrine as an intra-articular injection
Primary Outcome Measure Information:
Title
Analgesic efficacy
Description
VAS pain scores
Time Frame
1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
Title
Rescue narcotics use
Description
Opioid requirement due to pain
Time Frame
During post-surgical hospitalization
Title
Total narcotic consumption
Description
Opioid requirement overall
Time Frame
During post-surgical hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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