Study Stopped
Administratively closed early
Early Ambulation After Adductor Canal Block for Total Knee Arthroplasty
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
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 6, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedMarch 6, 2013
February 1, 2013
11 months
October 6, 2011
March 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ability to ambulate post operatively.
Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.
Up to 3 days (72 hours) post surgery.
Secondary Outcomes (2)
Pain scores at rest and with knee flexion.
Up to 3 days ( 72 hours) after surgery
Pain Medication Consumption
Up to 3 days (72 hours) post surgery
Study Arms (2)
Canal Block and Capsular Injection
EXPERIMENTALAdductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution.
Femoral with Tibial Nerve Block
ACTIVE COMPARATORContinuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- knee arthroplasty
- ages 18-80
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjay Sinha, M.D.
Saint Francis Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2011
First Posted
October 26, 2011
Study Start
October 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
March 6, 2013
Record last verified: 2013-02