Study to Evaluate ACB Versus FNB Early Postoperative Period Functional Outcomes After TKA
NCT ID: NCT02218814
Last Updated: 2016-02-02
Study Results
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Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2014-08-31
2016-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
80 Years
ALL
No
Sponsors
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Associated Anesthesiologists of Joliet
UNKNOWN
Statking Consulting, Inc.
INDUSTRY
George Macrinici
OTHER
Responsible Party
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George Macrinici
Physician
Principal Investigators
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George I Macrinici, MD
Role: PRINCIPAL_INVESTIGATOR
Presence Saint Joseph Medical Center
Locations
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Presence Saint Joseph Medical Center
Joliet, Illinois, United States
Countries
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References
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Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.
Chaumeron A, Audy D, Drolet P, Lavigne M, Vendittoli PA. Periarticular injection in knee arthroplasty improves quadriceps function. Clin Orthop Relat Res. 2013 Jul;471(7):2284-95. doi: 10.1007/s11999-013-2928-4. Epub 2013 Mar 21.
Wasserstein D, Farlinger C, Brull R, Mahomed N, Gandhi R. Advanced age, obesity and continuous femoral nerve blockade are independent risk factors for inpatient falls after primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1121-4. doi: 10.1016/j.arth.2012.08.018. Epub 2012 Dec 21.
Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
Andersen HL, Gyrn J, Moller L, Christensen B, Zaric D. Continuous saphenous nerve block as supplement to single-dose local infiltration analgesia for postoperative pain management after total knee arthroplasty. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):106-11. doi: 10.1097/AAP.0b013e31827900a9.
Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.
Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
Andersen LO, Gaarn-Larsen L, Kristensen BB, Husted H, Otte KS, Kehlet H. Analgesic efficacy of local anaesthetic wound administration in knee arthroplasty: volume vs concentration. Anaesthesia. 2010 Oct;65(10):984-90. doi: 10.1111/j.1365-2044.2010.06452.x.
Andersen LO, Husted H, Kristensen BB, Otte KS, Gaarn-Larsen L, Kehlet H. Analgesic efficacy of subcutaneous local anaesthetic wound infiltration in bilateral knee arthroplasty: a randomised, placebo-controlled, double-blind trial. Acta Anaesthesiol Scand. 2010 May;54(5):543-8. doi: 10.1111/j.1399-6576.2009.02196.x. Epub 2010 Jan 6.
Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.
Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173.
Macrinici GI, Murphy C, Christman L, Drescher M, Hughes B, Macrinici V, Diab G. Prospective, Double-Blind, Randomized Study to Evaluate Single-Injection Adductor Canal Nerve Block Versus Femoral Nerve Block: Postoperative Functional Outcomes After Total Knee Arthroplasty. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):10-16. doi: 10.1097/AAP.0000000000000507.
Related Links
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Other Identifiers
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10231969
Identifier Type: -
Identifier Source: org_study_id
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