NCT02554864

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

February 22, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

September 9, 2015

Last Update Submit

February 25, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cumulative 24 Hour Oral Morphine Equivalent Consumption

    Post-Operative Analgesia

    24 hours

  • 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 Outcomes (7)

  • Opioid Consumption

    During surgical procedure

  • Total opioids in Post Anesthetics (PAC)

    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

  • Pain Scores - Questionnaire

    24 hours post block

  • Quality of Recovery (QoR-15)

    24 hours postoperatively

  • Patient Satisfaction - Questionnaire

    24 hours postoperatively

  • +2 more secondary outcomes

Study Arms (3)

Adductor Canal Block- Injection -Site A

ACTIVE COMPARATOR

AC Block-Injection (lidocaine 2% and ropivacaine 1%) Site A - after the sartorius muscle crosses over the femoral artery

Drug: lidocaineDrug: ropivacaine

Adductor Canal Block - Injection -Site B

ACTIVE COMPARATOR

AC Block-Injection (lidocaine 2% and ropivacaine 1%) Site B - before the sartorius muscle crosses over the femoral artery

Drug: lidocaineDrug: ropivacaine

Adductor Canal Block -Injection -Site C

ACTIVE COMPARATOR

AC Block-Injection (lidocaine 2% and ropivacaine 1%) Site C - as the sartorius muscle crosses over the femoral artery

Drug: lidocaineDrug: ropivacaine

Interventions

Local anesthetic

Also known as: Xylocaine
Adductor Canal Block - Injection -Site BAdductor Canal Block -Injection -Site CAdductor Canal Block- Injection -Site A

Local anesthetic

Also known as: Naropin
Adductor Canal Block - Injection -Site BAdductor Canal Block -Injection -Site CAdductor Canal Block- Injection -Site A

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients booked for anterior cruciate ligament surgery under general anesthesia
  • English speaking
  • BMI \<38 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (22)

  • 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. No abstract available.

    PMID: 24534851BACKGROUND
  • 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. No abstract available.

    PMID: 23241724BACKGROUND
  • 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: 23820968BACKGROUND
  • 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. doi: 10.1097/aap.0b013e3181bfbf84.

    PMID: 19916251BACKGROUND
  • Krombach J, Gray AT. Sonography for saphenous nerve block near the adductor canal. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):369-70. doi: 10.1016/j.rapm.2007.04.006. No abstract available.

    PMID: 17720129BACKGROUND
  • 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. No abstract available.

    PMID: 19901788BACKGROUND
  • 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: 23241723BACKGROUND
  • 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. No abstract available.

    PMID: 19282716BACKGROUND
  • 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: 24121608BACKGROUND
  • 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.

    PMID: 25376972BACKGROUND
  • 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.

    PMID: 25154949BACKGROUND
  • Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.

    PMID: 25140514BACKGROUND
  • 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.

    PMID: 19920424BACKGROUND
  • 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.

    PMID: 23332436BACKGROUND
  • 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.

    PMID: 25496028BACKGROUND
  • 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.

    PMID: 22335278BACKGROUND
  • 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.

    PMID: 25337966BACKGROUND
  • 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.

    PMID: 25041873BACKGROUND
  • 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.

    PMID: 21697687BACKGROUND
  • 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: 22221014BACKGROUND
  • 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.

    PMID: 23549123BACKGROUND
  • 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. No abstract available.

    PMID: 20216039BACKGROUND

MeSH Terms

Interventions

LidocaineRopivacaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Richard Brull, MD

    University of Toronto, Women's College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 18, 2015

Study Start

February 22, 2016

Primary Completion

December 15, 2017

Study Completion

January 2, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations