Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty
Primary Purpose
Post-Operative Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proximal Adductor Canal Block
Distal Adductor Canal Block
Sponsored by
About this trial
This is an interventional treatment trial for Post-Operative Pain
Eligibility Criteria
Inclusion Criteria:
- Unilateral Total Knee Arthroplasty
- ASA physical status I-III
- >18 years old
- Non-pregnant
- Consent to participate in the study
Exclusion Criteria:
- Refusal to participate
- <18 years old
- Chronic opioid use
- Localized infection Pregnancy Pre-existing coagulopathy Allergy to ultrasound gel or local anesthetics Contraindication to or refusal of spinal anesthetic
Sites / Locations
- Virginia Mason Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Proximal
Distal
Arm Description
Proximal Adductor Canal Block
Distal Adductor Canal Block
Outcomes
Primary Outcome Measures
Opioid Consumption (IV Morphine Equivalents)
Total opioid consumption
Secondary Outcome Measures
Opioid Consumption (IV Morphine Equivalents)
Total opioid consumption
Pain (Numeric Rating)
NRS Pain Scale
Quadriceps Strength (% of Baseline)
Maximum Isometric Voluntary Contraction
Distance Ambulated (Feet)
Total distance ambulated during physical therapy
Full Information
NCT ID
NCT02701114
First Posted
February 29, 2016
Last Updated
July 11, 2017
Sponsor
Benaroya Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02701114
Brief Title
Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty
Official Title
A Comparison of Proximal Versus Distal Continuous Adductor Canal Blocks After Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benaroya Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to evaluate pain control of continuous adductor canal blocks placed proximally versus distally within the canal. The investigators hypothesize that there will be similar pain control between both groups.
Detailed Description
This study is a non-inferiority trial designed to determine whether placement of a continuous block within the adductor canal has a substantial impact on pain following total knee arthroplasty. Our primary outcome to determine this difference will be opioid consumption within the first day following surgery. Secondary outcomes will include: pain scores, quadriceps strength, and distance ambulated during physical therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proximal
Arm Type
Active Comparator
Arm Description
Proximal Adductor Canal Block
Arm Title
Distal
Arm Type
Active Comparator
Arm Description
Distal Adductor Canal Block
Intervention Type
Procedure
Intervention Name(s)
Proximal Adductor Canal Block
Intervention Description
Continuous Nerve Block
Intervention Type
Procedure
Intervention Name(s)
Distal Adductor Canal Block
Intervention Description
Continuous Nerve Block
Primary Outcome Measure Information:
Title
Opioid Consumption (IV Morphine Equivalents)
Description
Total opioid consumption
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Opioid Consumption (IV Morphine Equivalents)
Description
Total opioid consumption
Time Frame
48 Hours
Title
Pain (Numeric Rating)
Description
NRS Pain Scale
Time Frame
48 Hours
Title
Quadriceps Strength (% of Baseline)
Description
Maximum Isometric Voluntary Contraction
Time Frame
48 Hours
Title
Distance Ambulated (Feet)
Description
Total distance ambulated during physical therapy
Time Frame
48 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral Total Knee Arthroplasty
ASA physical status I-III
>18 years old
Non-pregnant
Consent to participate in the study
Exclusion Criteria:
Refusal to participate
<18 years old
Chronic opioid use
Localized infection Pregnancy Pre-existing coagulopathy Allergy to ultrasound gel or local anesthetics Contraindication to or refusal of spinal anesthetic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil A Hanson, MD
Organizational Affiliation
Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29140959
Citation
Meier AW, Auyong DB, Yuan SC, Lin SE, Flaherty JM, Hanson NA. Comparison of Continuous Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty: A Randomized, Double-Blind, Noninferiority Trial. Reg Anesth Pain Med. 2018 Jan;43(1):36-42. doi: 10.1097/AAP.0000000000000692.
Results Reference
derived
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Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty
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