NCT07732465

Brief Summary

Adductor Canal Block: Efficacy in Postoperative Pain Management for Cardiac Surgery

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
17mo left

Started Aug 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 2, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

June 2, 2026

Last Update Submit

July 23, 2026

Conditions

Keywords

Adductor canal blockNumeric Rating Scale (NRS)Coronary artery bypass grafting (CABG)SaphenectomyPostoperative periodPlacebo-controlled

Outcome Measures

Primary Outcomes (1)

  • Leg Pain at Rest

    The primary outcome will be leg pain at rest, measured using a numeric rating scale (NRS 0-10) at 3 hours, 6 hours, 12 hours, and 24 hours after the block injection. The NRS (Numeric Rating Scale) is a validated and widely used tool for assessing pain intensity in adults, particularly in postoperative and critical care settings. It allows for a simple, reproducible, and easily administered measurement, including during repeated assessments at the patient's bedside. The NRS scale consists of asking the patient to rate their pain on a numeric scale from 0 to 10, where: 0 corresponds to no pain at all 10 corresponds to the worst pain imaginable

    Numeric rating scale (NRS 0-10) will be performed at 3 hours, 6 hours, 12 hours, and 24 hours after the block injection.

Secondary Outcomes (9)

  • Total opioid consumption

    The first 48 postoperative hours after procedure

  • Postoperative pain unrelated to the saphenous territory

    Numeric rating scale (NRS 0-10) performed at 3 hours, 6 hours, 12 hours, and 24 hours after the block injection.

  • Persistent Postoperative Pain

    At 3 and 6 months postoperatively, assessed using the NRS.

  • Overall persistent postoperative pain

    At 3 and 6 months postoperatively.

  • Presence of hypoesthesia

    Numeric rating scale at 3 and 6 months.

  • +4 more secondary outcomes

Other Outcomes (3)

  • Use of co-analgesia

    Assessed once daily total co-analgesic doses administered, until discharge (an average of 7 days), up to 60 days.

  • Postoperative quality of life

    At 3 and 6 months postoperatively

  • Opioid use

    At 3 and 6 months postoperatively

Study Arms (2)

Adductor canal bloc with bupivacaine + dexmedetomidine

EXPERIMENTAL
Procedure: Aductor canal bloc

Control arm

PLACEBO COMPARATOR

Saline solution

Procedure: Control adductor canal block

Interventions

Adductor canal bloc with 0,25% bupivacaine + 20 ucg of dexmedetomidine

Also known as: Pain relief arm
Adductor canal bloc with bupivacaine + dexmedetomidine

Needle insertion mimicking the ACB procedure with injection of a saline solution

Control arm

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned CABG with unilateral or bilateral great saphenous vein (GSV) harvesting, without concomitant valve surgery
  • Age ≥ 18 years
  • Ability to understand the protocol and provide written informed consent
  • ASA physical status I-IV

You may not qualify if:

  • Refusal to participate in the study or inability to provide written informed consent
  • Contraindication to adductor canal block (e.g., local infection, allergy to local anesthetics)
  • Pre-existing chronic pain associated with chronic use of analgesic medications other than acetaminophen
  • Pre-existing peripheral neuropathy affecting the leg
  • Participation in two other interventional studies at the Montreal Heart Institute
  • Endoscopic vein harvesting performed by the surgical team instead of open saphenectomy technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (30)

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    BACKGROUND
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    PMID: 22660483BACKGROUND
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    PMID: 27389116BACKGROUND
  • Noiseux N, Prieto I, Bracco D, Basile F, Hemmerling T. Coronary artery bypass grafting in the awake patient combining high thoracic epidural and femoral nerve block: first series of 15 patients. Br J Anaesth. 2008 Feb;100(2):184-9. doi: 10.1093/bja/aem370.

    PMID: 18211992BACKGROUND
  • Jaya AAGPS, Tantri AR, Heriwardito A, Mansjoer A. Single-centre, double-blind, randomised, parallel-group, superiority study to evaluate the effectiveness of general anaesthesia and ultrasound-guided transversus thoracis muscle plane block combination in adult cardiac surgery for reducing the surgical stress response: clinical trial protocol. BMJ Open. 2021 Nov 11;11(11):e051008. doi: 10.1136/bmjopen-2021-051008.

    PMID: 34764171BACKGROUND
  • Vloka JD, Hadzic A, Mulcare R, Lesser JB, Kitain E, Thys DM. Femoral and genitofemoral nerve blocks versus spinal anesthesia for outpatients undergoing long saphenous vein stripping surgery. Anesth Analg. 1997 Apr;84(4):749-52. doi: 10.1097/00000539-199704000-00009.

    PMID: 9085951BACKGROUND
  • Yin W, Luo D, Xu W, Yang W, Jia S, Lin J. Effect of adductor canal block combined with infiltration between the popliteal artery and posterior capsular of the knee on chronic pain after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2024 Sep 10;24(1):320. doi: 10.1186/s12871-024-02707-2.

    PMID: 39256652BACKGROUND
  • Hasabo EA, Assar A, Mahmoud MM, Abdalrahman HA, Ibrahim EA, Hasanin MA, Emam AK, AbdelQadir YH, AbdelAzim AA, Ali AS. Adductor canal block versus femoral nerve block for pain control after total knee arthroplasty: A systematic review and Meta-analysis. Medicine (Baltimore). 2022 Aug 26;101(34):e30110. doi: 10.1097/MD.0000000000030110.

    PMID: 36042669BACKGROUND
  • Arnold, C., Alvarado, A. C., & Brady, M. F. (2023, May 23). Saphenous nerve block. In StatPearls [Internet]. StatPearls Publishing. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK536967/

    BACKGROUND
  • Rafiq S, Steinbruchel DA, Wanscher MJ, Andersen LW, Navne A, Lilleoer NB, Olsen PS. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial. J Cardiothorac Surg. 2014 Mar 20;9:52. doi: 10.1186/1749-8090-9-52.

    PMID: 24650125BACKGROUND
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    PMID: 33008722BACKGROUND
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    PMID: 29027773BACKGROUND
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    PMID: 15650984BACKGROUND
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    PMID: 34416847BACKGROUND
  • Routledge FS, Tsuyuki RT, Hervas-Malo M, LeBlanc P, McFetridge-Durdle JA, King KM. The influence of coronary artery bypass graft harvest site on women's pain, functional status, and health services utilization throughout the first post-operative year: a longitudinal study. Int J Nurs Stud. 2009 Aug;46(8):1054-60. doi: 10.1016/j.ijnurstu.2009.02.003. Epub 2009 Mar 9.

    PMID: 19269633BACKGROUND
  • Guimaraes-Pereira L, Reis P, Abelha F, Azevedo LF, Castro-Lopes JM. Persistent postoperative pain after cardiac surgery: a systematic review with meta-analysis regarding incidence and pain intensity. Pain. 2017 Oct;158(10):1869-1885. doi: 10.1097/j.pain.0000000000000997.

    PMID: 28767509BACKGROUND
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    PMID: 37969009BACKGROUND
  • Chernyavskiy A, Volkov A, Lavrenyuk O, Terekhov I, Kareva Y. Comparative results of endoscopic and open methods of vein harvesting for coronary artery bypass grafting: a prospective randomized parallel-group trial. J Cardiothorac Surg. 2015 Nov 12;10:163. doi: 10.1186/s13019-015-0353-3.

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    BACKGROUND
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  • National Heart, Lung, and Blood Institute. (2023). Coronary artery bypass grafting (CABG). In Coronary Artery Disease (pp. 1-10). National Institutes of Health. https://www.ncbi.nlm.nih.gov/books/NBK507836/

    BACKGROUND

Central Study Contacts

Christian Ayoub, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

July 29, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared, as study documents are available only in French. However, upon reasonable request, the investigators will provide the study protocol, informed consent form, statistical analysis plan, and any other relevant documents.

Locations