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Early Ambulation After Adductor Canal Block for Total Knee Arthroplasty

This study has been terminated.
(Administratively closed early)
Sponsor:
Information provided by (Responsible Party):
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT01459861
First received: October 6, 2011
Last updated: March 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Pain
Osteoarthritis
 Procedure: Canal Block and Capsular Injection
Procedure: Femoral Nerve Block with Tibial Nerve Block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Saint Francis Care:

Primary Outcome Measures:
  • Ability to ambulate post operatively. [ Time Frame: Up to 3 days (72 hours) post surgery. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Up to 3 days ( 72 hours) after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 days (72 hours) post surgery ] [ Designated as safety issue: No ]
    Amount of opioid consumption post surgery for 72 hours.


Enrollment: 11
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01459861     History of Changes
Other Study ID Numbers: 11-09-003
Study First Received: October 6, 2011
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Francis Care:
early ambulation
knee arthroplasty

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

ClinicalTrials.gov processed this record on May 21, 2013