Effect of Volume of Local Anesthetic for Adductor Canal Block on Quadriceps Muscle Function: A Dose Finding Study

NCT02541552 | Completed Phase 3

• 1 other identifier: ADDCAN05
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Adductor canal block is commonly offered to provide pain relief following knee surgery with the hope that they cause less leg weakness than traditionally performed femoral nerve block. Infrequently, adductor canal blocks also result in leg weakness thereby potentially limiting the advantages of the technique. Investigators want to find out the effective dose for a 30% response (volume of local anesthetic which would result in clinically significant weakness of the leg)

Conditions

Postoperative Pain

Keywords

Knee arthroscopy; Quadriceps weakness; ropivacaine; saphenous nerve block; Adductor canal

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the EV50 of anesthetic volume needed to produce >30% reduction of pre-injectate quadriceps strength at 20 minutes following adductor canal block.

  Measured by handheld dynamometer

  Percentage difference before block and at 20minutes

Secondary Outcomes (2)

• Reduced sensation to pin-prick around the anteromedial aspect of the knee

  20 minutes post-block

• Post-operative quadriceps muscle function

  Percentage difference before block and at 4 hours following block

Study Arms (1)

Knee arthroscopic patient

EXPERIMENTAL

1\) Male and females 2) Age 16-60 years 3) Scheduled surgery 4) Knee arthroscopy 5) ASA Class I - III Volume finding study to follow up-and-down design using a single cohort of patients. Intervention of patient will be dependent on effect of previous patients dose of and response to Ropivacaine 0.5% injectate.

Drug: Ropivacaine 0.5%

Interventions

Ropivacaine 0.5% DRUG

Varying volume according to motor response of previous subject

Also known as: Naropin

Knee arthroscopic patient

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and females
• Age 16-60 years
• Scheduled surgery
• Knee arthroscopy
• ASA Class I - III

You may not qualify if:

• Ipsi- or contralateral leg weakness
• Preoperative neurological deficits
• Narcotic dependent (opioid intake more than 3 months)
• Chronic pain conditions
• Significant cardiac and respiratory disease
• Coexisting hematological disorder or with deranged coagulation parameters
• Pre-existing major organ dysfunction such as hepatic and renal failure.
• Psychiatric illnesses
• Emergency surgery
• Lack of informed consent
• Allergy to any of the drugs used in the study

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

LHSC University Hospital

London, Ontario, N6G 2V4, Canada

Location

Related Publications (13)

• Hanson NA, Derby RE, Auyong DB, Salinas FV, Delucca C, Nagy R, Yu Z, Slee AE. Ultrasound-guided adductor canal block for arthroscopic medial meniscectomy: a randomized, double-blind trial. Can J Anaesth. 2013 Sep;60(9):874-80. doi: 10.1007/s12630-013-9992-9. Epub 2013 Jul 3.

  PMID: 23820968 BACKGROUND

• Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.

  PMID: 18574578 BACKGROUND

• Rawal N. Postoperative pain treatment for ambulatory surgery. Best Pract Res Clin Anaesthesiol. 2007 Mar;21(1):129-48. doi: 10.1016/j.bpa.2006.11.005.

  PMID: 17489224 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

• 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.

  PMID: 24401769 BACKGROUND

• Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):67-72. doi: 10.1016/j.rapm.2006.08.013.

  PMID: 17196495 BACKGROUND

• Mayr HO, Entholzner E, Hube R, Hein W, Weig TG. Pre- versus postoperative intraarticular application of local anesthetics and opioids versus femoral nerve block in anterior cruciate ligament repair. Arch Orthop Trauma Surg. 2007 May;127(4):241-4. doi: 10.1007/s00402-006-0147-0. Epub 2006 May 23.

  PMID: 16721618 BACKGROUND

• Chen J, Lesser JB, Hadzic A, Reiss W, Resta-Flarer F. Adductor canal block can result in motor block of the quadriceps muscle. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):170-1. doi: 10.1097/AAP.0000000000000053.

  PMID: 24553306 BACKGROUND

• Veal C, Auyong DB, Hanson NA, Allen CJ, Strodtbeck W. Delayed quadriceps weakness after continuous adductor canal block for total knee arthroplasty: a case report. Acta Anaesthesiol Scand. 2014 Mar;58(3):362-4. doi: 10.1111/aas.12244. Epub 2013 Dec 26.

  PMID: 24372058 BACKGROUND

• Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.

  PMID: 21044725 BACKGROUND

• Bohannon RW, Kindig J, Sabo G, Duni AE, Cram P. Isometric knee extension force measured using a handheld dynamometer with and without belt-stabilization. Physiother Theory Pract. 2012 Oct;28(7):562-8. doi: 10.3109/09593985.2011.640385. Epub 2011 Dec 22.

  PMID: 22191509 BACKGROUND

• 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.

  PMID: 24121608 BACKGROUND

• Johnston DF, Sondekoppam RV, Giffin R, Litchfield R, Ganapathy S. Determination of ED50 and ED95 of 0.5% Ropivacaine in Adductor Canal Block to Produce Quadriceps Weakness: A Dose-Finding Study. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):731-736. doi: 10.1097/AAP.0000000000000638.

  PMID: 28991061 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: September 4, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 25, 2016

Record last verified: 2016-08

Locations

CA (1)