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Adductor Canal Block With Posterior Capsular Injection for Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT01805661
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Saint Francis Care

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Osteoarthritis Procedure: Canal Block and Capsular Injection Procedure: Femoral with Tibial Nerve Block Not Applicable

Detailed Description:
Early mobilization in the postoperative period is important to the success of surgery following total knee replacement. However, severe post-operative pain is an impediment to early implementation of rehabilitaion program. The use of femoral nerve block combined with tibial nerve block as part of a multimodal analgesic program provides effective pain control but causes weakness of the operative extremity preventing patients from bearing weight, exercising the leg and increasing the risk of falls thereby delaying early participation in rehabilitation. Adductor canal block is a new technique that has been described to provide pain control after total knee arthroplasty (1). The advantages of this block is that it could potentially minimize lower extremity weakness because the target nerve (saphenous nerve) blocked in this technique is a purely sensory nerve and does not provide any motor innervation to any muscle groups. Adductor canal block lends itself easily to providing prolonged analgesia because a perineural catheter can be inserted and the block maintained by a continuous infusion of dilute local anesthetic solution for days. A disadvantage of this method is that it may not provide adequate analgesia for posterior knee pain in the early postoperative period. By combining adductor canal block with ultrasound guided posterior and antero-medial knee injection, the posterior knee pain can be controlled effectively. Posterior and antero-medial knee injection of local anesthetic solution has been used as a method of controlling posterior knee pain after total knee arthroplasty (2).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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 vs Continuous Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement.
Study Start Date : March 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01805661     History of Changes
Other Study ID Numbers: 12-10-002
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: January 2015

Keywords provided by Saint Francis Care:
early ambulation
knee arthroplasty

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