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Study to Evaluate ACB Versus FNB Early Postoperative Period Functional Outcomes After TKA (ACB)

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ClinicalTrials.gov Identifier: NCT02218814
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : February 2, 2016
Sponsor:
Collaborators:
Associated Anesthesiologists of Joliet
Statking Consulting, Inc.
Information provided by (Responsible Party):
George Macrinici, Presence Saint Joseph Medical Center

Study Description
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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 outcomes compared to individuals who receive a femoral nerve block and local infiltration during the first 24 hours post surgery.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Nerve Block Procedure: Adductor Canal Block, Bupivacaine Procedure: Femoral Nerve Block, Bupivacaine Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 Period Functional Outcomes After Total Knee Replacement
Study Start Date : August 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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Arm Intervention/treatment
Experimental: Adductor Canal Block:
Adductor Canal Nerve Block: The patient is placed in a supine position with the extremity to be blocked slightly externally rotated. On the medial thigh, at the midpoint between the inguinal crease and the medial condyle, 13-6-MHz linear ultrasound transducer (SonoSite HFL38x; Washington, US) is placed in a transverse orientation to visualize the femoral artery in short axis deep to the sartorius muscle. Sterile field and patient sedation achieved. A 21-gauge,100 mm, short-bevel needle (Stimuplex; B Braun) is inserted under ultrasound guidance in in-plane technique to position the needle tip anterolateral to the artery and just deep to the posterior fascia of the sartorius muscle. Once in position, 30 mL of Bupivacaine (100 mg) is deposited adjacent to the femoral artery and deep to the Sartorius muscle, using intermittent aspiration. After completion of the procedure, a sterile dressing is placed over the needle insertion site.
 Procedure: Adductor Canal Block, Bupivacaine

Adductor Canal Nerve Block: Under US guidance and sterile technique 30 mL (100 mg) of Bupivacaine is deposited adjacent to the femoral artery and deep to the Sartorius muscle, using intermittent aspiration.

Femoral Nerve Block: Under US guidance, using a twitch monitor and sterile technique, 30 ml of PF Normal Saline is deposited adjacent to the femoral artery at the level of inguinal crease.

Other Names:
  • ACB
  • Bupivacaine
  • FNB
  • Preservative Free Normal Saline
Active Comparator: Femoral Nerve Block
Femoral Nerve Block. The procedure is conducted with the patient in a supine position with a 13-6 MHz linear ultrasound transducer (SonoSite HFL38x; Washington, US) applied to the skin at the level of the inguinal crease. The femoral artery, fascia iliac, and femoral nerve are visualized. Sterile field and patient sedation achieved. A 22-gauge, 50-mm, short-bevel stimulating needle (Stimuplex; B Braun, Bethlehem, Pennsylvania) connected to twitch monitor B/Braun Stimuplex DIG RC is inserted under ultrasound guidance using an in-plane technique from lateral to medial until a quadriceps motor response is elicited at a current between 0.5 and 0.2 mA with a pulse width of 0.1millisecond from a twitch monitor . After negative aspiration, 30 mL of Bupivacaine (100 mg) is deposited adjacent to the femoral nerve and deep to the fascia iliac, with intermittent aspiration. After completion of the procedure, a sterile dressing is placed over the needle insertion site.
 Procedure: Femoral Nerve Block, Bupivacaine

Femoral Nerve Block: Under US guidance, using a twitch monitor and sterile technique, 30 ml (100 mg) of Bupivacaine is deposited adjacent to the femoral artery at the level of inguinal crease.

Adductor Canal Nerve Block: Under US guidance and sterile technique 30 mL of PF Normal Saline is deposited adjacent to the femoral artery and deep to the Sartorius muscle, using intermittent aspiration.

Other Names:
  • FNB
  • Bupivacaine
  • ACB
  • Preservative Free Normal Saline


Outcome Measures
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Primary Outcome Measures :
  1. Quadriceps muscle strength (MVIC) difference between the ACB and FNB after total knee arthroplasty. [ Time Frame: Baseline, 6, 24, 48 hours and at 6 month after nerve block performance ]
    Maximum Voluntary Isovolumetric Contraction (MVIC) measured in Newtons of the quadriceps muscle normalized to body mass index (N•m/kg). The 6 hours post procedure percent of baseline is considered the primary clinical success criterion variable of this study.


Secondary Outcome Measures :
  1. Knee range of motion [ Time Frame: Baseline, 6, 24 48 hours and 6 month after the nerve block performance ]
    Knee range of motion is measured as a combined flexion/extension either actively or passively with assistance. Knee range of motion is typically measured in the supine position. The examiner will measure knee flexion passively using a goniometer. It has been validated as an outcome measure in total knee arthroplasty. To be able to navigate stairs 90 degrees of flexion is required. To adequately perform activities of daily living (ADL's), 110 degrees of flexion is required. The minimum detectable change in knee flexion for an individual is 9.6 degrees.

  2. Time Up and Go [ Time Frame: Baseline, 24, 48 hours and 6 month after the nerve block performance ]
    The TUG test records the time taken to stand up from a standard height arm chair, walk 3m, walk back to the chair, and sit down. It is meant to assess a patients balance and risk of falling. Assistive devices, for example, a walker, are allowed to be used if needed. This test has been validated as an early functional outcome after TKA. Maximum improvement occurs between the sixth and ninth postoperative weeks, with a plateau at 10 weeks. Freely independent patients are able to complete the task in 10 seconds, whereas a time greater than 30 seconds corresponds to patients being dependent in most activities. The minimum detectable change is 2.5 seconds.

  3. 6 Minute Walk Test [ Time Frame: Baseline and at 6 month after the surgery ]
    The 6-Minute Walk Test (6MWT) records the maximum distance ambulated on level ground without physical assistance in six minutes with standardized encouragement. It has been validated for evaluation of functional outcome after TKA. Assistive devices are allowed if needed. The minimum distance that is required to perform ADL's is 300m. After TKA, increase in 6MWT distance typically follow pattern where maximal improvement occurs in the first 12 weeks postoperatively, specifically between weeks 6 and 9, followed by a slower improvement between weeks 12 and 26, reaching a plateau at 26 weeks. The minimum detectable change (MDC) for the 6MWT is reported to be 61.3m.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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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): NCT02218814


Locations
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United States, Illinois
Presence Saint Joseph Medical Center
Joliet, Illinois, United States, 60435
Sponsors and Collaborators
George Macrinici
Associated Anesthesiologists of Joliet
Statking Consulting, Inc.
Investigators
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Principal Investigator: George I Macrinici, MD Presence Saint Joseph Medical Center
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: George Macrinici, Physician, Presence Saint Joseph Medical Center
ClinicalTrials.gov Identifier: NCT02218814    
Other Study ID Numbers: 10231969
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Keywords provided by George Macrinici, Presence Saint Joseph Medical Center:
Femoral Nerve Block
Adductor Canal Nerve Block
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents