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

January 29, 2016 updated by: George Macrinici

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Period Functional Outcomes after Total Knee Arthroplasty.

Objectives:

Primary: To determine if patients undergoing a Total Knee Arthroplasty who receive an Adductor Canal block will result in increased quadriceps muscle strength (MVIC) compared to those who receive a Femoral Nerve block at 24 hours.

Secondary: The secondary objective is to determine whether Adductor Canal nerve block results in improved functional outcomes as evidenced by Time up and GO, Range of Motion and Six-Minute Walk Test at 24 hours, 48 hours and 6 months.

To assess post-operative pain as measured by the Visual Analog pain score (VAS) immediately prior to the start of, during, and after each in-patient physical therapy session.

Study Design: Prospective, double-blind, randomized study

Description of Intervention: The devices to be used in this study are intended for nerve blocks and consist of 13-6 MHz linear ultrasound transducer (SonoSite HFL38x; Washington, US), a 22-gauge, 50-mm, short-bevel stimulating needle (Stimuplex; B Braun, Bethlehem, Pennsylvania), B/Braun Stimuplex DIG RC, Bupivacaine HCl 100 mg injected in the Adductor Canal or around the Femoral nerve.

Femoral nerve block in combination with local infiltration analgesia is the standard of care in the investigators institution at present.

Bupivacaine HCl 100 mg in combination with Toradol 30 mg are used for local infiltration of the anterior lateral and lateral posterior side of the knee, done by the surgeon using a standard technique.

Subject Population:The study will include both male and female adults who will meet the inclusion criteria and none of exclusion criteria. For each patient time to conduct the blocks will vary between 5-10 minutes, local infiltration analgesia between 5-10 minutes, physical therapy tests between 30 minutes and one hour each encounter, VAS pain assessment between 2-5 minutes

Subject Participation Duration:The rate of patient accrual, and the prescribed follow-up time, the total duration of this study is expected to be approximately 18 months where enrollment is expected to occur over 12 months with a follow-up period of 6 months in the physical therapy office visits.

Number of Patients:The study will include 120 patients.

Number of Sites: The study will include one site.

Study Duration:The expected study duration is approximately 18 months.

Endpoints: Endpoints of this study will include quadriceps muscle strength, ROM of the knee, TUG, 6 minute walk test, knee pain score (VAS), activities of daily living, adverse events and will be studied from the baseline up to 6 month after TKR. VAS pain score will be assessed at each physical therapy encounter.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Presence Saint Joseph Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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:
  • Bupivacaine
  • ACB
  • 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:
  • Bupivacaine
  • ACB
  • FNB
  • Preservative Free Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6, 24, 48 hours and at 6 month after nerve block performance

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6, 24 48 hours and 6 month after the nerve block performance
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.
Baseline, 24, 48 hours and 6 month after the nerve block performance
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.
Baseline and at 6 month after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Macrinici

Collaborators

Associated Anesthesiologists of Joliet
Statking Consulting, Inc.

Investigators

  • Principal Investigator: George I Macrinici, MD, Presence Saint Joseph Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10231969

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthroplasty, Replacement, Knee

Clinical Trials on Adductor Canal Block, Bupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe