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

Arthroplasty, Replacement, Knee Clinical Trial

— ACB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218814
• Other study ID #: 10231969
• Status: Completed
• Phase: N/A
• First received: August 1, 2014
• Last updated: January 29, 2016
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Presence Saint Joseph Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board Presence Saint Joseph Medical Center
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Nerve Block

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Presence Saint Joseph Medical Center	Joliet	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
George Macrinici	Associated Anesthesiologists of Joliet, Statking Consulting, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (13)

Andersen HL, Gyrn J, Møller 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. — View Citation

Andersen LØ, 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. — View Citation

Andersen LØ, 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. — View Citation

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. Erratum in: Clin Orthop Relat Res. 2013 Jun;471(6):2042. — View Citation

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. — View Citation

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. — View Citation

Jæger 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. — View Citation

Jenstrup MT, Jæger 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps muscle strength (MVIC) difference between the ACB and FNB after total knee arthroplasty.	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	No
Secondary	Knee range of motion	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	No
Secondary	Time Up and Go	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	Yes
Secondary	6 Minute Walk Test	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	No

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