Back to resultsEarly Ambulation After Adductor Canal Block for Total Knee Arthroplasty
Primary Purpose
Pain, Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Canal Block and Capsular Injection
Femoral Nerve Block with Tibial Nerve Block
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring early ambulation, knee arthroplasty
Eligibility Criteria
Inclusion Criteria:
- knee arthroplasty
- ages 18-80
Exclusion Criteria:
- history of neurological disease
- diabetes
- pregnancy
- neuropathy
- chronic narcotic use
- allergy to local anesthetic solution or NSAIDS
- inability to give consent or cooperate with the study protocol
Sites / Locations
- Saint Francis Hospital and Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Canal Block and Capsular Injection
Femoral with Tibial Nerve Block
Arm Description
Adductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution.
Continuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa.
Outcomes
Primary Outcome Measures
Ability to ambulate post operatively.
Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.
Secondary Outcome Measures
Pain scores at rest and with knee flexion.
Measures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 72 hour period after discharge from recovery room.
Pain Medication Consumption
Amount of opioid consumption post surgery for 72 hours.
Full Information
NCT ID
NCT01459861
First Posted
October 6, 2011
Last Updated
March 4, 2013
Sponsor
Trinity Health Of New England
1. Study Identification
Unique Protocol Identification Number
NCT01459861
Brief Title
Early Ambulation After Adductor Canal Block for Total Knee Arthroplasty
Official Title
Assessment of Early Ambulation in Patients Receiving Continuous Adductor Canal Block With Ultrasound Guided Posterior Capsular Knee Injection vs. Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively closed early
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trinity Health Of New England
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess early ambulation following total knee replacement in patients receiving continuous adductor canal block with posterior capsular injection compared to continuous femoral nerve block with tibial nerve block.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Osteoarthritis
Keywords
early ambulation, knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canal Block and Capsular Injection
Arm Type
Experimental
Arm Description
Adductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution.
Arm Title
Femoral with Tibial Nerve Block
Arm Type
Active Comparator
Arm Description
Continuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa.
Intervention Type
Procedure
Intervention Name(s)
Canal Block and Capsular Injection
Intervention Description
Continuous Adductor canal block with 15ml of ropivacaine 0.2% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30ml ropivacaine 0.2% with epinephrine 1:400,000.
Intervention Type
Procedure
Intervention Name(s)
Femoral Nerve Block with Tibial Nerve Block
Intervention Description
Continuous femoral nerve block with 15ml of ropivacaine 0.2% followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.5% up to 15ml.
Primary Outcome Measure Information:
Title
Ability to ambulate post operatively.
Description
Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.
Time Frame
Up to 3 days (72 hours) post surgery.
Secondary Outcome Measure Information:
Title
Pain scores at rest and with knee flexion.
Description
Measures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 72 hour period after discharge from recovery room.
Time Frame
Up to 3 days ( 72 hours) after surgery
Title
Pain Medication Consumption
Description
Amount of opioid consumption post surgery for 72 hours.
Time Frame
Up to 3 days (72 hours) post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
knee arthroplasty
ages 18-80
Exclusion Criteria:
history of neurological disease
diabetes
pregnancy
neuropathy
chronic narcotic use
allergy to local anesthetic solution or NSAIDS
inability to give consent or cooperate with the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Sinha, M.D.
Organizational Affiliation
Saint Francis Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Ambulation After Adductor Canal Block for Total Knee Arthroplasty
We'll reach out to this number within 24 hrs