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Early Ambulation After Adductor Canal Block for Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01459861
Recruitment Status : Terminated (Administratively closed early)
First Posted : October 26, 2011
Last Update Posted : March 6, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Pain Osteoarthritis Procedure: Canal Block and Capsular Injection Procedure: Femoral Nerve Block with Tibial Nerve Block

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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 Start Date : October 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Canal Block and Capsular Injection
Adductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution.
Procedure: Canal Block and Capsular Injection
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.
Active Comparator: Femoral with Tibial Nerve Block
Continuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa.
Procedure: Femoral Nerve Block with Tibial Nerve Block
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.


Outcome Measures

Primary Outcome Measures :
  1. Ability to ambulate post operatively. [ Time Frame: Up to 3 days (72 hours) post surgery. ]
    Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.


Secondary Outcome Measures :
  1. Pain scores at rest and with knee flexion. [ Time Frame: Up to 3 days ( 72 hours) after surgery ]
    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.

  2. Pain Medication Consumption [ Time Frame: Up to 3 days (72 hours) post surgery ]
    Amount of opioid consumption post surgery for 72 hours.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459861


Locations
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Saint Francis Care
Investigators
Principal Investigator: Sanjay Sinha, M.D. Saint Francis Memorial Hospital
More Information

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01459861     History of Changes
Other Study ID Numbers: 11-09-003
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: February 2013

Keywords provided by Saint Francis Care:
early ambulation
knee arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases