- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02701114
Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty
July 11, 2017 updated by: Neil Hanson, Benaroya Research Institute
A Comparison of Proximal Versus Distal Continuous Adductor Canal Blocks After Total Knee Arthroplasty
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Proximal
Proximal Adductor Canal Block
|
Continuous Nerve Block
|
Active Comparator: Distal
Distal Adductor Canal Block
|
Continuous Nerve Block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Consumption (IV Morphine Equivalents)
Time Frame: 24 Hours
|
Total opioid consumption
|
24 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Consumption (IV Morphine Equivalents)
Time Frame: 48 Hours
|
Total opioid consumption
|
48 Hours
|
Pain (Numeric Rating)
Time Frame: 48 Hours
|
NRS Pain Scale
|
48 Hours
|
Quadriceps Strength (% of Baseline)
Time Frame: 48 Hours
|
Maximum Isometric Voluntary Contraction
|
48 Hours
|
Distance Ambulated (Feet)
Time Frame: 48 Hours
|
Total distance ambulated during physical therapy
|
48 Hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil A Hanson, MD, Virginia Mason Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
February 29, 2016
First Submitted That Met QC Criteria
March 2, 2016
First Posted (Estimate)
March 8, 2016
Study Record Updates
Last Update Posted (Actual)
July 13, 2017
Last Update Submitted That Met QC Criteria
July 11, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB15118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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