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AnesthesiaLILACNCT02554864

Location of Injection of Local Anesthetics in the Adductor Canal Block

A study testing lidocaine and ropivacaine in people with Anesthesia and Adductor Canal Block, run by Women's College Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Anesthesia, Adductor Canal Block
What is being tested?
lidocaine and ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteCanada
Study dates
22 Feb 2016to 2 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Women's College Hospital

    Toronto, Ontario, M5S 1B2

Other trials in Canada

About this study

Official title: Location of Injection of Local Anesthetics in the Adductor Canal Block: A Randomized Controlled Trial of the Effect on Postoperative Analgesia and Motor Power

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.

Read the detailed 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.

Being tested
lidocaine, ropivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lidocaineDrug

    Also called Xylocaine

    Local anesthetic

  • ropivacaineDrug

    Also called Naropin

    Local anesthetic

Study groups in NCT02554864
Study groupRoleWhat they receive
Adductor Canal Block- Injection -Site AActive comparatorAC Block-Injection (lidocaine 2% and ropivacaine 1%) Site A - after the sartorius muscle crosses over the femoral artery
Receives: Drug: lidocaine; Drug: ropivacaine
Adductor Canal Block - Injection -Site BActive comparatorAC Block-Injection (lidocaine 2% and ropivacaine 1%) Site B - before the sartorius muscle crosses over the femoral artery
Receives: Drug: lidocaine; Drug: ropivacaine
Adductor Canal Block -Injection -Site CActive comparatorAC Block-Injection (lidocaine 2% and ropivacaine 1%) Site C - as the sartorius muscle crosses over the femoral artery
Receives: Drug: lidocaine; Drug: ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative 24 Hour Oral Morphine Equivalent Consumption

    Post-Operative Analgesia

    Measured: 24 hours

  2. 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

    Measured: 30 Minutes post Block

Secondary outcomes (7)

  1. Opioid Consumption

    Intra-operative opioid consumption

    Measured: During surgical procedure

  2. Total opioids in Post Anesthetics (PAC)

    Cumulative oral morphine equivalent consumption in PACU

    Measured: 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

  3. Pain Scores - Questionnaire

    Area under the curve for rest pain scores plotted against time during the first 24 hours

    Measured: 24 hours post block

  4. Quality of Recovery (QoR-15)

    Quality of recovery measured using the QoR-15 at 24 hours postoperatively

    Measured: 24 hours postoperatively

  5. Patient Satisfaction - Questionnaire

    Patient satisfaction with analgesia - NRS Pain Scale 0(no pain to 10(worst pain)

    Measured: 24 hours postoperatively

  6. Hospital Discharge (Time to hospital discharge)

    Time to hospital discharge

    Measured: Same day as surgical procedure

  7. Nerve Block Complications

    Presence/absence of nerve block complications during the first 24 hours postoperatively and 2 weeks after surgery

    Measured: 24 hours postoperatively and 2 weeks postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2015 (estimated)
  2. Study start22 Feb 2016
  3. Primary completion15 Dec 2017
  4. Study completion2 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02554864
Sponsor's protocol ID
2015-0046-B
Acronym
LILAC
Status last verified
Feb 2019
First submitted
9 Sep 2015
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24534851

  • 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.

    PubMed 23241724

  • 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.

    PubMed 23820968

  • 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.

    PubMed 19916251

  • 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.

    PubMed 17720129

  • 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.

    PubMed 19901788

  • 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.

    PubMed 23241723

  • 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.

    PubMed 19282716

  • 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.

    PubMed 24121608

  • 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.

    PubMed 25376972

  • 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.

    PubMed 25154949

  • 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.

    PubMed 25140514

  • 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.

    PubMed 19920424

  • 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.

    PubMed 23332436

  • 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.

    PubMed 25496028

Questions about this trial

What is this clinical trial studying?

A study testing lidocaine and ropivacaine in people with Anesthesia and Adductor Canal Block, run by Women's College Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative 24 Hour Oral Morphine Equivalent Consumption (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02554864, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.

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