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

July 23, 2026 updated by: Montreal Heart Institute

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adductor canal bloc with bupivacaine + dexmedetomidine
Procedure: Aductor canal bloc
Adductor canal bloc with 0,25% bupivacaine + 20 ucg of dexmedetomidine
Other Names:
  • Pain relief arm
Placebo Comparator: Control arm
Saline solution
Procedure: Control adductor canal block
Needle insertion mimicking the ACB procedure with injection of a saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid consumption
Time Frame: The first 48 postoperative hours after procedure
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).
The first 48 postoperative hours after procedure
Postoperative pain unrelated to the saphenous territory
Time Frame: Numeric rating scale (NRS 0-10) performed at 3 hours, 6 hours, 12 hours, and 24 hours after the block injection.

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
Numeric rating scale (NRS 0-10) performed at 3 hours, 6 hours, 12 hours, and 24 hours after the block injection.
Persistent Postoperative Pain
Time Frame: At 3 and 6 months postoperatively, assessed using the NRS.

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
At 3 and 6 months postoperatively, assessed using the NRS.
Overall persistent postoperative pain
Time Frame: At 3 and 6 months postoperatively.

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
At 3 and 6 months postoperatively.
Presence of hypoesthesia
Time Frame: Numeric rating scale at 3 and 6 months.

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
Numeric rating scale at 3 and 6 months.
Neuropathic characterization
Time Frame: At 48 hours, 3 months, and 6 months.

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
At 48 hours, 3 months, and 6 months.
Block safety
Time Frame: Assessed daily during hospitalization until patient is discharge from the hospital (an average of 7 days), up to 60 days.
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.
Assessed daily during hospitalization until patient is discharge from the hospital (an average of 7 days), up to 60 days.
Opioid-related side effects
Time Frame: 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.
Incidence of common opioid-related side effects in each group, including nausea, vomiting, and constipation.
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.
Time to extubation
Time Frame: At extubation
Time to extubation after adductor canal block
At extubation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of co-analgesia
Time Frame: Assessed once daily total co-analgesic doses administered, until discharge (an average of 7 days), up to 60 days.
Number of treatments used and frequency of use (lidocaine-ketamine cream, NSAIDs, gabapentinoids, etc.)
Assessed once daily total co-analgesic doses administered, until discharge (an average of 7 days), up to 60 days.
Postoperative quality of life
Time Frame: At 3 and 6 months postoperatively

EQ-5D score quantification measured at 3 and 6 months postoperatively. The EQ-5D (EuroQol - 5 Dimensions) is a standardized and validated instrument used to assess health-related quality of life across two components. It is widely used in clinical research to measure the overall impact of a medical intervention on patients' functional status and well-being.

It explores five dimensions of health:

  • Mobility
  • Self-care
  • Usual activities
  • Pain / discomfort
  • Anxiety / depression

Each dimension is assessed across 5 levels of severity:

  • No problems
  • Slight problems
  • Moderate problems
  • Severe problems
  • Extreme problems / inability

The combination of responses generates a 5-digit health profile, which can be converted into an EQ-5D index.

1.0: Represents perfect health. 0.0: Represents a state considered equivalent to death. Negative values: Health states deemed "worse than death."
At 3 and 6 months postoperatively
Opioid use
Time Frame: At 3 and 6 months postoperatively
Opioid use at 3 and 6 months postoperatively, assessed by the presence or absence of opioid use and the type of opioid used.
At 3 and 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026-3693 MHI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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