Status:
COMPLETED
Study to Evaluate ACB Versus FNB Early Postoperative Period Functional Outcomes After TKA
Lead Sponsor:
George Macrinici
Collaborating Sponsors:
Associated Anesthesiologists of Joliet
Statking Consulting, Inc.
Conditions:
Arthroplasty, Replacement, Knee
Nerve Block
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if patients undergoing a Total Knee Arthroplasty who receive a single shot Adductor Canal nerve block and local infiltration will have improved functional out...
Detailed Description
Title: Prospective, Double-blind, Randomized Study to Evaluate a Single Shot Adductor Canal Nerve Block versus Femoral Nerve Block combined with LIA (Local Infiltration Analgesia): Early Postoperative...
Eligibility Criteria
Inclusion
- Subject is 40-80 years of age and skeletally mature
- Subject BMI is \< 40
- Subject has been selected by the surgeon for TKA.
- Subject is taking less than 30 mg of Morphine per day.
- Subject is willing and able to sign a written consent form
- The subject has the mental capacity and the willingness to comply with the specified follow-up evaluations, and can be contacted by telephone by the site personnel.
- The subject is not pregnant, does not intend to become pregnant and has a significant other mirroring her intentions.
Exclusion
- Subject is not neurologically intact (sensory, motor, and reflex deficit)
- Subject has pain in the limb scheduled for surgery that is out of proportion of expected pain usual for this pathology
- Subject scheduled for simultaneous bilateral knee replacement
- Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years
- Subject with prior reconstructive knee surgery on the operated limb
- Subject with primary bone tumor in the knee area
- Subject anticipates having a lower extremity surgery other than the investigational surgery during the course of the study
- Subject has a history of substance abuse
- Subject is currently involved in another study or have received investigational product or treatment within the last 30 days
- Subject is pregnant or planning on becoming pregnant during the study period
- Subject is accepting workers' compensation
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02218814
Start Date
August 1 2014
End Date
January 1 2016
Last Update
February 2 2016
Active Locations (1)
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1
Presence Saint Joseph Medical Center
Joliet, Illinois, United States, 60435