Study to Evaluate ACB Versus FNB Early Postoperative Period Functional Outcomes After TKA
Condition: Arthroplasty, Replacement, Knee; Nerve Block
Study type: Interventional

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: 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.
    

Intervention name(s): Adductor Canal Block, Bupivacaine; Femoral Nerve Block, Bupivacaine
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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 intervention name(s): ACB; Bupivacaine; FNB; Preservative Free Normal Saline; FNB; Bupivacaine; ACB; Preservative Free Normal Saline
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Femoral Nerve Block; Adductor Canal Nerve Block