Adductor Canal Block in an Enhanced Recovery Program After Total Knee Arthroplasty

NCT03915522 | Unknown

• 1 other identifier: CEIC-1806
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectivity of adductor canal block performed the day after total knee arthroplasty surgery in reducing pain and improving walking ambulation ability and muscle strength.

Conditions

Total Knee Arthroplasty; Knee Osteoarthritis

Keywords

total kee arthroplasty; adductor canal block; multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• Change in postoperative pain score at rest and knee flexion: Numerical Rating Scale

  Assessed using a Numerical Rating Scale (NRS) from 0 to 10

  Registered immediately prior to surgery, first postoperative day immediately prior to procedure, 2 hours postprocedure and every 8 hours the first three days in the orthopedic ward.

Secondary Outcomes (9)

• Knee extensor muscle strength

  Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention

• Adductor muscle strength

  Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention

• Ability to walk with ten meter walk test

  First and second postoperative day every 12 hours

• Rate of pain rescue treatments.

  First 72 hours following surgery

• Rate of opioid side effects.

  First 72 hours following surgery

Study Arms (2)

Adductor Canal Block

EXPERIMENTAL

Patients will receive multi-modal analgesia (oral, intravenous and local infiltration anesthesia) for pain management following total knee arthroplasty and in the first postoperative day a single adductor canal block wiht 20cc of 0.5% Ropivacaine using ultrasound guidance .

Procedure: Single adductor canal block

Placebo Comparator

PLACEBO COMPARATOR

Patients will receive multi-modal analgesia (oral, intravenous and local infiltration anesthesia) for pain management following total knee arthroplasty and in the first postoperative day a sham adductor canal block with 2ml of 1% subcutaneous lidocaine at the level of the adductor canal using ultrasound guidance.

Procedure: Simulated adductor canal block

Interventions

Single adductor canal block PROCEDURE

The operated leg is slightly externally rotated and prepared for a block with 2% chlorhexidine and sterile dressing. The adductor canal is identified using ultrasound image at the mid-thigh level and after a subcutaneous injection of 2 ml of 1% lidocaine a total of 20 ml of 0'5% ropivacaine is injected into the canal using a 22 gauge ultrasound-visible needle. In the end, a sterile apposite is placed at the puncture site

Adductor Canal Block

Simulated adductor canal block PROCEDURE

The operated leg is slightly externally rotated and prepared with 2% chlorhexidine and sterile dressing. The adductor canal is identified using ultrasound image at the mid-thigh level and at this leve a subcutaneous injection of 2 ml of 1% lidocaine . After, a sterile apposite is placed at the puncture site.

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective unilateral total knee arthroplasty
• American Society of Anesthesiologist (ASA) class 1-3
• Adults aged 18-85 years old

You may not qualify if:

• Contraindications of the adductor canal block.
• Contraindications of the local infiltration analgesia technique.
• Chronic kidney disease
• Surgery to be performed under general anesthesia.
• Opioid treatment \> 30 mgr morphine or equivalent for more than 3 months time.
• Neuropathic ipsilateral pain.
• Inability to understand study procedures.
• Not acceptance of the procedure (adductor canal block or local infiltration analgesia).

Sponsors & Collaborators

• Institut de Recerca Biomèdica de Lleida: lead

Study Sites (1)

Hospital Universitary Santa Maria

Lleida, 25198, Spain

RECRUITING

Related Publications (19)

• Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.

  PMID: 16651569 BACKGROUND

• Andersen LO, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17.

  PMID: 24939863 BACKGROUND

• Xu CP, Li X, Wang ZZ, Song JQ, Yu B. Efficacy and safety of single-dose local infiltration of analgesia in total knee arthroplasty: a meta-analysis of randomized controlled trials. Knee. 2014 Jun;21(3):636-46. doi: 10.1016/j.knee.2014.02.024. Epub 2014 Mar 13.

  PMID: 24704172 BACKGROUND

• Sawhney M, Mehdian H, Kashin B, Ip G, Bent M, Choy J, McPherson M, Bowry R. Pain After Unilateral Total Knee Arthroplasty: A Prospective Randomized Controlled Trial Examining the Analgesic Effectiveness of a Combined Adductor Canal Peripheral Nerve Block with Periarticular Infiltration Versus Adductor Canal Nerve Block Alone Versus Periarticular Infiltration Alone. Anesth Analg. 2016 Jun;122(6):2040-6. doi: 10.1213/ANE.0000000000001210.

  PMID: 27028771 BACKGROUND

• Fajardo M, Collins J, Landa J, Adler E, Meere P, Di Cesare PE. Effect of a perioperative intra-articular injection on pain control and early range of motion following bilateral TKA. Orthopedics. 2011 May 18;34(5):354. doi: 10.3928/01477447-20110317-11.

  PMID: 21598890 BACKGROUND

• 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.

  PMID: 22221014 BACKGROUND

• 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.

  PMID: 22834681 BACKGROUND

• 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.

  PMID: 23222363 BACKGROUND

• Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.

  PMID: 25386752 BACKGROUND

• Hanson NA, Allen CJ, Hostetter LS, Nagy R, Derby RE, Slee AE, Arslan A, Auyong DB. Continuous ultrasound-guided adductor canal block for total knee arthroplasty: a randomized, double-blind trial. Anesth Analg. 2014 Jun;118(6):1370-7. doi: 10.1213/ANE.0000000000000197.

  PMID: 24842182 BACKGROUND

• Kuang MJ, Xu LY, Ma JX, Wang Y, Zhao J, Lu B, Ma XL. Adductor canal block versus continuous femoral nerve block in primary total knee arthroplasty: A meta-analysis. Int J Surg. 2016 Jul;31:17-24. doi: 10.1016/j.ijsu.2016.05.036. Epub 2016 May 19.

  PMID: 27212592 BACKGROUND

• Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.

  PMID: 24401802 BACKGROUND

• 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.

  PMID: 23241723 BACKGROUND

• 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.

  PMID: 23788068 BACKGROUND

• Dong CC, Dong SL, He FC. Comparison of Adductor Canal Block and Femoral Nerve Block for Postoperative Pain in Total Knee Arthroplasty: A Systematic Review and Meta-analysis. Medicine (Baltimore). 2016 Mar;95(12):e2983. doi: 10.1097/MD.0000000000002983.

  PMID: 27015172 BACKGROUND

• Hussain N, Ferreri TG, Prusick PJ, Banfield L, Long B, Prusick VR, Bhandari M. Adductor Canal Block Versus Femoral Canal Block for Total Knee Arthroplasty: A Meta-Analysis: What Does the Evidence Suggest? Reg Anesth Pain Med. 2016 May-Jun;41(3):314-20. doi: 10.1097/AAP.0000000000000376. No abstract available.

  PMID: 27035459 BACKGROUND

• Li D, Yang Z, Xie X, Zhao J, Kang P. Adductor canal block provides better performance after total knee arthroplasty compared with femoral nerve block: a systematic review and meta-analysis. Int Orthop. 2016 May;40(5):925-33. doi: 10.1007/s00264-015-2998-x. Epub 2015 Oct 10.

  PMID: 26452678 BACKGROUND

• Vora MU, Nicholas TA, Kassel CA, Grant SA. Adductor canal block for knee surgical procedures: review article. J Clin Anesth. 2016 Dec;35:295-303. doi: 10.1016/j.jclinane.2016.08.021. Epub 2016 Oct 11.

  PMID: 27871547 BACKGROUND

• Ma J, Gao F, Sun W, Guo W, Li Z, Wang W. Combined adductor canal block with periarticular infiltration versus periarticular infiltration for analgesia after total knee arthroplasty. Medicine (Baltimore). 2016 Dec;95(52):e5701. doi: 10.1097/MD.0000000000005701.

  PMID: 28033266 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Reis Drudis Morell, MD

CONTACT

34630011138; reisdrudis@gmail.com

Jordi Colomina Morales, MD

CONTACT

34 679513862; jordicolomina82@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All patients included in the study are transferred the day after the total knee arthroplasty surgery to the postoperative resuscitation unit. A sterile dressing of the lower extremity is performed and after the adductor canal is identified with ultrasound image, a medial leg puncture is done with or without doing the canal adductor block. At the end all patients have a sterile apposite on the puncture site. All variables and outcomes are collected and registered by people not involved in the realization of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A simple randomization is made to distribute the included patients in two groups: Standard Group and Intervention Group. A table of random numbers is used, first selecting the starting point and later the movement direction remains constant throughout the whole table. The even numbers are allocated in the standard group and the odd ones in the intervention group.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 16, 2019
• Study Start: May 14, 2018
• Primary Completion: September 2, 2019
• Study Completion: September 2, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)