Adductor Canal Block With Posterior Capsular Injection for Total Knee Replacement

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT01805661
First received: March 4, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

To compare early ambulation and ability to participate in rehabilitation in patients undergoing total knee replacement using two different nerve block techniques for pain control. The 2 methods are 1) Adductor canal block with posterior capsular injection 2) femoral nerve block with tibial nerve block


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Assessment of Early Ambulation and Participation in Rehabilitation Program in Patients Receiving Continuous Adductor Canal Block With Ultrasound Guided Posterior Capsular Knee Injection Versus Continuous Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement.

Resource links provided by NLM:


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: 56
Study Start Date: March 2013
Estimated Study Completion Date: October 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Femoral With Tibial Nerve Block
Continuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa
Procedure: Femoral with Tibial Nerve Block
Continuous femoral nerve block with 15 ml of ropivacaine 0.1% followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.1% up to 15 ml.
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 15-30ml of ropivacaine 0.1% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30 ml ropivacaine 0.1% with epinephrine 1:400,000.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having primary, unilateral total knee arthroplasty
  • ages 18 - 80

Exclusion Criteria:

  • history of neurological disease
  • neuropathy
  • diabetes
  • major systemic illness
  • pregnancy
  • chronic narcotic use
  • allergy to local anesthetic solution or NSAIDS
  • inability to give consent or cooperate with the study protocol
  • BMI> 40
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805661

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 Hospital and Medical Center
  More Information

No publications provided

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01805661     History of Changes
Other Study ID Numbers: 12-10-002
Study First Received: March 4, 2013
Last Updated: March 10, 2014
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 August 01, 2014