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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541552
• Other study ID #: ADDCAN05
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2015
• Last updated: August 24, 2016
• Start date: April 2015
• Est. completion date: November 2015

Study information

• Verified date: August 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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)

Description:

This is a sequential design method of binary response variables for determination of the dose associated with the 50% point along the dose-response curve required to cause quadriceps weakness following adductor canal bock for knee arthroscopic procedures. It is a Dixon and Massey up-and-down study design.

The primary objective is finding the EV50 of 0.5% ropivacaine needed to cause a 30% reduction in quadriceps function 20 minutes post-procedure.

This study design was selected to allow the estimation of the target dose associated with the given outcome of quadriceps weakness. The study will be performed on 36 patients undergoing knee arthroscopic procedures. The quadriceps strength on both legs will be evaluated preoperatively by the physiotherapist.

The quadriceps function will be measured using a hand held dynamometer (HDD). For quadriceps muscle strength evaluation, investigators will place the patient in a seated position with the knees flexed 60 degrees. To avoid interrater reliability (when the strength of the subject overcomes the strength of the tester) investigators will fix the HHD for quadriceps evaluation. A non-elastic strap with Velcro closures will be used to fix the HHD. The Velcro strap will be attached to a chair leg and around the subject's ankle, perpendicular to the lower leg. The HHD will be placed under the Velcro strap, on the anterior surface of the tibia, 5 cm above the transmalleolar axis.

Subjects will be educated about the procedure before outcome assessments. They will be instructed to take 2 seconds to reach maximum effort, maintain this force for 3 seconds, and then relax. For each assessment, the subjects will perform 3 consecutive contractions, separated by a 30-second pause between each trial. Investigators will use the mean value at each time point for calculations, and calculated muscle strength as percent of baseline value. An independent investigator not involved in the performance of the block will assess the quadriceps muscle function before, 20 minutes and then 4 hours after the block.

Following initial motor assessment the patients will be taken to the block room for the blocks to be performed using standard monitors which will include NIBP and pulse oximetry.

Patients will be sedated with fentanyl and midazolam titrated to effect and supplemental oxygen will be administered.The first patient will be given 30ml of ropivacaine 0.5% in the adductor canal block.

Depending on post-operative quadriceps function, the dose for the subsequent patient will either be increased by 2ml or decreased by 2ml (of the same concentration).

The adductor canal block procedure will be standardised for each patients. All patients will receive ultrasound guided saphenous nerve block in the adductor canal using 0.5% ropivacaine. After preparing the skin with chlorhexidine in alcohol solution and draping the area, the puncture sites will be infiltrated with 2% lidocaine. A 22 gauge 90 mm peripheral nerve stimulation block needle will be introduced deep to the sartorius muscle using ultrasonography and a linear high frequency probe and 30 ml (initially) of 0.5% ropivacaine will be injected after negative aspiration for blood while observing the spread of injectate.

The injection will be done above the level where the descending genicular artery is taking off from the femoral artery. The cutaneous analgesia over the medial aspect of leg will be tested to evaluate the success of saphenous nerve block 20 minutes after injection. If the descending genicular artery is not visualised on ultrasound, then the block will be performed proximal to where the femoral artery enters the hiatus in adductor magnus.

Total duration of performance and the time for the onset of sensory block in saphenous distribution will be recorded after the performance of the block. The failure rate of saphenous nerve block will be determined by the performer. Patients with failure of saphenous nerve block will be excluded from the efficacy part of the study.

After performance of the blocks, the patient will be moved to the operating room for the surgery under general anesthesia according to the choice of the anesthesiologist.

The patients will be assessed for the severity of pain after arrival in the PACU for four hours. Patients quadriceps function will be measured at 4 hours post-operatively. Complications such as bruising and post-block neurological deficits will be prospectively collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male and females

• Age 16-60 years

• Scheduled surgery

• Knee arthroscopy

• ASA Class I - III

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ropivacaine 0.5%
Varying volume according to motor response of previous subject

Locations

Country	Name	City	State
Canada	LHSC University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (12)

Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gümüs 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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

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

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. Epub 2006 May 23. — View Citation

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. — View Citation

Rawal N. Postoperative pain treatment for ambulatory surgery. Best Pract Res Clin Anaesthesiol. 2007 Mar;21(1):129-48. Review. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Reduced sensation to pin-prick around the anteromedial aspect of the knee	Used to verify successful adductor canal block. scoring of either 0 - normal sensation and can feel pin-prick, 1 - touch only, 2 - no sensation of touch or pinprick	20 minutes post-block	No
Secondary	Post-operative quadriceps muscle function	Measured by handheld dynamometer	Percentage difference before block and at 4 hours following block	No