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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Quadriceps muscle strength (MVIC) difference between the ACB and FNB after total knee arthroplasty.
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- 6 Minute Walk Test(Baseline and at 6 month after the surgery)
- Knee range of motion(Baseline, 6, 24 48 hours and 6 month after the nerve block performance)
- Time Up and Go(Baseline, 24, 48 hours and 6 month after the nerve block performance)
Investigators
George Macrinici
Physician
Presence Saint Joseph Medical Center