Back to resultsUltrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
Primary Purpose
Total Knee Arthroplasty
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous proximal adductor canal block
Continuous femoral nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Total Knee Arthroplasty focused on measuring a continuous proximal adductor canal block (ACB), continuous femoral nerve block (FNB)
Eligibility Criteria
Inclusion Criteria:
- Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score of 1 or 2 that are healthy without systemic disease or have mild systemic disease, respectively.
- The patient will need to be able to have decision-making capacity and ability to consent for the study.
Exclusion Criteria:
- Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score greater than 2.
- Patients unable to have decision-making capacity and ability to consent for the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
adductor canal block (ACB)
femoral nerve block (FNB)
Arm Description
Subjects randomized to this groups receive a continuous proximal adductor canal block (ACB) during surgery.
Subjects randomized to this groups receive a continuous femoral nerve block (FNB) during surgery.
Outcomes
Primary Outcome Measures
Motor effects
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.
Secondary Outcome Measures
Pain score
Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.
Pain score
Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.
Opioid consumption
Subjects' pain will be assessed by tracking opioid consumption postoperatively.
Opioid consumption
Subjects' pain will be assessed by tracking opioid consumption postoperatively.
Motor effects
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02495805
Brief Title
Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
Official Title
Ultrasound-guided Continuous Proximal Adductor Canal Versus Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study never officially began- currently closed with IRB.
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to compare continuous femoral nerve block with continuous proximal adductor canal block for postoperative pain control and rehabilitation.
Detailed Description
Patients meeting the criteria: American Society of Anesthesiologists (ASA) class I and II, that are scheduled for elective total knee arthroplasty, will be recruited into the study. Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty
Keywords
a continuous proximal adductor canal block (ACB), continuous femoral nerve block (FNB)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
adductor canal block (ACB)
Arm Type
Active Comparator
Arm Description
Subjects randomized to this groups receive a continuous proximal adductor canal block (ACB) during surgery.
Arm Title
femoral nerve block (FNB)
Arm Type
Active Comparator
Arm Description
Subjects randomized to this groups receive a continuous femoral nerve block (FNB) during surgery.
Intervention Type
Procedure
Intervention Name(s)
Continuous proximal adductor canal block
Other Intervention Name(s)
ACB
Intervention Description
Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
Intervention Type
Procedure
Intervention Name(s)
Continuous femoral nerve block
Other Intervention Name(s)
FNB
Intervention Description
Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
Primary Outcome Measure Information:
Title
Motor effects
Description
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.
Time Frame
24 hours (postoperatively)
Secondary Outcome Measure Information:
Title
Pain score
Description
Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.
Time Frame
On average between 6 and 8 hours postoperatively
Title
Pain score
Description
Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.
Time Frame
24 hours (postoperatively)
Title
Opioid consumption
Description
Subjects' pain will be assessed by tracking opioid consumption postoperatively.
Time Frame
On average between 6 and 8 hours postoperatively
Title
Opioid consumption
Description
Subjects' pain will be assessed by tracking opioid consumption postoperatively.
Time Frame
24 hours (postoperatively)
Title
Motor effects
Description
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.
Time Frame
On average between 6 and 8 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score of 1 or 2 that are healthy without systemic disease or have mild systemic disease, respectively.
The patient will need to be able to have decision-making capacity and ability to consent for the study.
Exclusion Criteria:
Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score greater than 2.
Patients unable to have decision-making capacity and ability to consent for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richa Wardham, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
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