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Coronary Artery Bypass Grafting (CABG) SurgeryPhase 2/3AddEaseNCT07732465

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

A Phase 2/3 study testing Aductor canal bloc in people with Coronary Artery Bypass Grafting (CABG) Surgery and Saphenectomy, run by Montreal Heart Institute at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Adductor Canal Block: Efficacy in Postoperative Pain Management for Cardiac Surgery Read more about this study

Who is it for?
Ages 18 to 110 years
What is being tested?
Aductor canal bloc
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteCanada
Study dates
1 Aug 2026to 31 Dec 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christian Ayoub, MD contact

5147088999

ayoub_christian@hotmail.com

Canada1 site
  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

    Abir Attia, Msc., 5143763330, abir.attia@icm-mhi.org

Other trials in Canada

About this study

Official title: Effectiveness of Adductor Canal Block in Postoperative Co-analgesia for Cardiac Surgery With Saphenous Vein Harvesting

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

Being tested
Aductor canal bloc, Control adductor canal block
Keywords
Adductor canal block, Numeric Rating Scale (NRS), Coronary artery bypass grafting (CABG), Saphenectomy, Postoperative period, Placebo-controlled

What participants receive

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

  • Aductor canal blocProcedure or surgery

    Also called Pain relief arm

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

  • Control adductor canal blockProcedure or surgery

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

Study groups in NCT07732465
Study groupRoleWhat they receive
Adductor canal bloc with bupivacaine + dexmedetomidineExperimentalNot described
Receives: Procedure: Aductor canal bloc
Control armPlacebo comparatorSaline solution
Receives: Procedure: Control adductor canal block

What is being measured

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

  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

    Measured: 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)
  1. Total opioid consumption

    Cumulative amount administered, expressed in morphine milligram equivalents (MME), during the first 48 postoperative hours (conversion factors used: hydromorphone 1 mg = morphine 5 mg; fentanyl 100 µg = morphine 10 mg).

    Measured: The first 48 postoperative hours after procedure

  2. Postoperative pain unrelated to the saphenous territory

    Incidence and characterization of postoperative pain unrelated to the saphenous territory (e.g., thoracic or musculoskeletal pain), assessed at the same time points as saphenous pain using a numeric rating scale (NRS 0-10).

    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

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

  3. Persistent Postoperative Pain

    Proportion of patients reporting pain ≥4/10 at the harvest site at 3 and 6 months postoperatively, assessed using the NRS.

    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

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

  4. Overall persistent postoperative pain

    Proportion of patients reporting pain ≥4/10 (all sites combined) at 3 and 6 months postoperatively.

    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

    Measured: At 3 and 6 months postoperatively.

  5. Presence of hypoesthesia

    Presence of hypoesthesia (non-painful) at the saphenectomy site at 3 and 6 months using a numeric rating scale (NRS 0-10).

    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

    Measured: Numeric rating scale at 3 and 6 months.

  6. Neuropathic characterization

    Quantification of the modified DN4 score at the harvest site at 48 hours, 3 months, and 6 months.

    Modified DN4 ≥ 3/8: high probability of neuropathic pain Modified DN4 < 3/8: neuropathic pain unlikely

    Measured: At 48 hours, 3 months, and 6 months.

  7. Block safety

    Number of adverse events related to the adductor canal block observed during the hospital stay, including hematoma, infection, nerve injury, cardiovascular complications, motor block, and signs of local anesthetic systemic toxicity.

    Measured: Assessed daily during hospitalization until patient is discharge from the hospital (an average of 7 days), up to 60 days.

  8. Opioid-related side effects

    Incidence of common opioid-related side effects in each group, including nausea, vomiting, and constipation.

    Measured: Each time the patient takes opioids during in the postoperative period until discharge from the hospital (an average of 7 days), up to 60 days.

  9. Time to extubation

    Time to extubation after adductor canal block

    Measured: At extubation

Timeline

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

  1. First posted29 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07732465
Sponsor's protocol ID
2026-3693 MHI
Acronym
AddEase
Status last verified
Jul 2026
First submitted
2 Jun 2026
Last updated
29 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • El Tallawy SN, Ali WA, Thallaj AK, Ahmed RS, Manaa EM, Mostafa MS, Aljasser FF, Amlih HF, Hassanin AA. Comparative study between surgical wound catheter, femoral nerve block, and adductor canal block for postoperative analgesia after knee arthroplasty: A double blind randomized clinical trial. Saudi J Anaesth. 2023 Jul-Sep;17(3):359-367. doi: 10.4103/sja.sja_894_22. Epub 2023 Mar 15.

    PubMed 37601506
  • Moon, N., & Lin, E. (2025, May 23). Adductor canal block. OpenAnesthesia. https://www.openanesthesia.org/keywords/adductor-canal-block

  • Moradian ST, Najafloo M, Mahmoudi H, Ghiasi MS. Early mobilization reduces the atelectasis and pleural effusion in patients undergoing coronary artery bypass graft surgery: A randomized clinical trial. J Vasc Nurs. 2017 Sep;35(3):141-145. doi: 10.1016/j.jvn.2017.02.001.

    PubMed 28838589
  • Grant MC, Crisafi C, Alvarez A, Arora RC, Brindle ME, Chatterjee S, Ender J, Fletcher N, Gregory AJ, Gunaydin S, Jahangiri M, Ljungqvist O, Lobdell KW, Morton V, Reddy VS, Salenger R, Sander M, Zarbock A, Engelman DT. Perioperative Care in Cardiac Surgery: A Joint Consensus Statement by the Enhanced Recovery After Surgery (ERAS) Cardiac Society, ERAS International Society, and The Society of Thoracic Surgeons (STS). Ann Thorac Surg. 2024 Apr;117(4):669-689. doi: 10.1016/j.athoracsur.2023.12.006. Epub 2024 Jan 28.

    PubMed 38284956
  • Fujita Y, Mera H, Watanabe T, Furutani K, Kondo HO, Wakai T, Kawashima H, Ogose A. Significantly earlier ambulation and reduced risk of near-falls with continuous infusion nerve blocks: a retrospective pilot study of adductor canal block compared to femoral nerve block in total knee arthroplasty. BMC Musculoskelet Disord. 2022 Aug 12;23(1):768. doi: 10.1186/s12891-022-05735-6.

    PubMed 35953812
  • Al Wahbi AM. Evaluation of pain during endovenous laser ablation of the great saphenous vein with ultrasound-guided femoral nerve block. Vasc Health Risk Manag. 2017 Aug 10;13:305-309. doi: 10.2147/VHRM.S135308. eCollection 2017.

    PubMed 28860790
  • Li YH, Wang T, Qian C, Chen GP, Lou WS, Gu JP. Application of Femoral Nerve Block in Treating Great Saphenous Vein Insufficiency by Endovenous Radiofrequency Ablation Combined with Punctate Stripping. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231220054. doi: 10.1177/10760296231220054.

    PubMed 38130118
  • Dzieciuchowicz L, Espinosa G, Grochowicz L. Evaluation of ultrasound-guided femoral nerve block in endoluminal laser ablation of the greater saphenous vein. Ann Vasc Surg. 2010 Oct;24(7):930-4. doi: 10.1016/j.avsg.2009.10.022. Epub 2010 Jul 3.

    PubMed 20598852
  • Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

    PubMed 29026331
  • Liu SS, Buvanendran A, Rathmell JP, Sawhney M, Bae JJ, Moric M, Perros S, Pope AJ, Poultsides L, Della Valle CJ, Shin NS, McCartney CJ, Ma Y, Shah M, Wood MJ, Manion SC, Sculco TP. A cross-sectional survey on prevalence and risk factors for persistent postsurgical pain 1 year after total hip and knee replacement. Reg Anesth Pain Med. 2012 Jul-Aug;37(4):415-22. doi: 10.1097/AAP.0b013e318251b688.

    PubMed 22660483
  • Thomazeau J, Rouquette A, Martinez V, Rabuel C, Prince N, Laplanche JL, Nizard R, Bergmann JF, Perrot S, Lloret-Linares C. Predictive Factors of Chronic Post-Surgical Pain at 6 Months Following Knee Replacement: Influence of Postoperative Pain Trajectory and Genetics. Pain Physician. 2016 Jul;19(5):E729-41.

    PubMed 27389116
  • 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.

    PubMed 18211992
  • 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.

    PubMed 34764171
  • 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.

    PubMed 9085951
  • 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.

    PubMed 39256652

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Aductor canal bloc in people with Coronary Artery Bypass Grafting (CABG) Surgery and Saphenectomy, run by Montreal Heart Institute 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Christian Ayoub, MD (5147088999, ayoub_christian@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Leg Pain at Rest (time frame: Numeric rating scale (NRS 0-10) will be performed at 3 hours, 6 hours, 12 hours, and 24 hours after the block injection.). 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 NCT07732465, which also lists 30 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 29 Jul 2026.

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