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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02554864
Other study ID # 2015-0046-B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 22, 2016
Est. completion date January 2, 2018

Study information

Verified date February 2019
Source Women's College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The adductor canal block (ACB) is the standard of care for analgesia after Anterior Cruciate Ligament (ACL) repair. ACB is performed by injecting local anesthetic (freezing) in the subsartorial canal in the thigh which is about 7-10cm long. Preliminary evidence suggests that different injection sites within the canal may produce different degrees of analgesia and quadriceps motor block. This trial seeks to determine the effects of various ACB injection sites on postoperative analgesia and motor power following ACL repair.


Description:

Adductor canal block (ACB) is replacing femoral nerve block (FNB) as the peripheral nerve block of choice for knee surgery. The ACB aims to inject local anesthetics (LA) within the neurovascular sheath in the subsartorial adductor canal around the femoral nerve. The point where the sartorius muscle crosses over the femoral artery is generally the accepted site for performing ACB. Clinically, injecting LA in the adductor canal blocks the sensory innervation of the knee and thus offers pain relief that is similar to FNB while conserving motor power around the knee. While these benefits are desirable, the exact location for performing ACB that ensures these benefits, remains debatable. The subsartorial adductor canal itself is 7-10cm long and the anatomical location of the sensory and motor nerves that innervate the knee and its surrounding muscles in this canal may vary. This randomized controlled trial is designed to identify and refine the ACB technique by clinically determining the effects of various ACB injection locations on postoperative analgesia and quadriceps motor power following ACL repair.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date January 2, 2018
Est. primary completion date December 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Patients booked for anterior cruciate ligament surgery under general anesthesia

- English speaking

- BMI <38 kg/m2

Exclusion Criteria:

- Refusal or inability to provide informed consent

- Allergy to local anesthetics

- Contraindication to regional anesthesia including coagulopathy or bleeding - diathesis

- Infection

- Nerve Injury at the site of the nerve block

- Malignancy at the site of the nerve block

- History of drug and/or alcohol dependence

- History of long term opioid intake or chronic pain disorder

- History of pre-existing neuropathy in the operative leg

- History of significant psychiatric conditions that may affect patient assessment

- Inability to understand the informed consent and demands of the study

- Allergy to any of the components of multi-modal analgesic regimen

- Revision ACL repair

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
lidocaine
Local anesthetic
ropivacaine
Local anesthetic

Locations

Country Name City State
Canada Women's College Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (22)

Andersen HL, Andersen SL, Tranum-Jensen J. The spread of injectate during saphenous nerve block at the adductor canal: a cadaver study. Acta Anaesthesiol Scand. 2015 Feb;59(2):238-45. doi: 10.1111/aas.12451. Epub 2014 Dec 14. — View Citation

Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Børglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. — View Citation

Chi J, Chiu B, Cao Y, Liu X, Wang J, Balu N, Yuan C, Xu J. Assessment of femoral artery atherosclerosis at the adductor canal using 3D black-blood MRI. Clin Radiol. 2013 Apr;68(4):e213-21. doi: 10.1016/j.crad.2012.12.002. Epub 2013 Jan 17. — View Citation

Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. — View Citation

Espelund M, Fomsgaard JS, Haraszuk J, Mathiesen O, Dahl JB. Analgesic efficacy of ultrasound-guided adductor canal blockade after arthroscopic anterior cruciate ligament reconstruction: a randomised controlled trial. Eur J Anaesthesiol. 2013 Jul;30(7):422-8. doi: 10.1097/EJA.0b013e328360bdb9. — View Citation

Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169. — 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

Head SJ, Leung RC, Hackman GP, Seib R, Rondi K, Schwarz SK. Ultrasound-guided saphenous nerve block--within versus distal to the adductor canal: a proof-of-principle randomized trial. Can J Anaesth. 2015 Jan;62(1):37-44. doi: 10.1007/s12630-014-0255-1. Epub 2014 Oct 22. — View Citation

Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af. — View Citation

Ilfeld BM, Hadzic A. Walking the tightrope after knee surgery: optimizing postoperative analgesia while minimizing quadriceps weakness. Anesthesiology. 2013 Feb;118(2):248-50. doi: 10.1097/ALN.0b013e318279fa3a. — 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

Kapoor R, Adhikary SD, Siefring C, McQuillan PM. The saphenous nerve and its relationship to the nerve to the vastus medialis in and around the adductor canal: an anatomical study. Acta Anaesthesiol Scand. 2012 Mar;56(3):365-7. doi: 10.1111/j.1399-6576.2011.02645.x. — View Citation

Kirkpatrick JD, Sites BD, Antonakakis JG. Preliminary experience with a new approach to performing an ultrasound-guided saphenous nerve block in the mid to proximal femur. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):222-3. doi: 10.1097/AAP.0b013e3181d24589. — View Citation

Krombach J, Gray AT. Sonography for saphenous nerve block near the adductor canal. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):369-70. Erratum in: Reg Anesth Pain Med. 2007 Nov-Dec;32(6):536. — View Citation

Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. — View Citation

Mariano ER, Kim TE, Wagner MJ, Funck N, Harrison TK, Walters T, Giori N, Woolson S, Ganaway T, Howard SK. A randomized comparison of proximal and distal ultrasound-guided adductor canal catheter insertion sites for knee arthroplasty. J Ultrasound Med. 2014 Sep;33(9):1653-62. doi: 10.7863/ultra.33.9.1653. — View Citation

Mariano ER, Perlas A. Adductor canal block for total knee arthroplasty: the perfect recipe or just one ingredient? Anesthesiology. 2014 Mar;120(3):530-2. doi: 10.1097/ALN.0000000000000121. — View Citation

Saranteas T, Anagnostis G, Paraskeuopoulos T, Koulalis D, Kokkalis Z, Nakou M, Anagnostopoulou S, Kostopanagiotou G. Anatomy and clinical implications of the ultrasound-guided subsartorial saphenous nerve block. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):399-402. doi: 10.1097/AAP.0b013e318220f172. — View Citation

Shah NA, Jain NP. Is continuous adductor canal block better than continuous femoral nerve block after total knee arthroplasty? Effect on ambulation ability, early functional recovery and pain control: a randomized controlled trial. J Arthroplasty. 2014 Nov;29(11):2224-9. doi: 10.1016/j.arth.2014.06.010. Epub 2014 Jun 19. — View Citation

Tsui BC, Ozelsel T. Ultrasound-guided transsartorial perifemoral artery approach for saphenous nerve block. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):177-8; author reply 178. doi: 10.1097/AAP.0b013e31819a273e. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative 24 Hour Oral Morphine Equivalent Consumption Post-Operative Analgesia 24 hours
Primary Motor Power - Peak Force as measured by a dynamometer Percentage decrease in quadriceps motor strength at 30 minutes following adductor canal block compare to baseline 30 Minutes post Block
Secondary Opioid Consumption Intra-operative opioid consumption During surgical procedure
Secondary Total opioids in Post Anesthetics (PAC) Cumulative oral morphine equivalent consumption in PACU Total length of time in PACU (total time in minutes from arrival in PACU to discharge to the Surgical Day Care is between 60-180 minutes
Secondary Pain Scores - Questionnaire Area under the curve for rest pain scores plotted against time during the first 24 hours 24 hours post block
Secondary Quality of Recovery (QoR-15) Quality of recovery measured using the QoR-15 at 24 hours postoperatively 24 hours postoperatively
Secondary Patient Satisfaction - Questionnaire Patient satisfaction with analgesia - NRS Pain Scale 0(no pain to 10(worst pain) 24 hours postoperatively
Secondary Hospital Discharge (Time to hospital discharge) Time to hospital discharge Same day as surgical procedure
Secondary Nerve Block Complications Presence/absence of nerve block complications during the first 24 hours postoperatively and 2 weeks after surgery 24 hours postoperatively and 2 weeks postoperatively
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