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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-110
SponsorMontreal Heart Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aductor canal bloc

    Procedure/Surgery

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

  • Control adductor canal block

    Procedure/Surgery

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Adductor canal bloc with bupivacaine + dexmedetomidineExperimental treatment 1 intervention
Group B: Control armPlacebo comparator 1 intervention

Trial outcomes

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

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.

Secondary outcomes

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).

Time frame
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

Time frame
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

Time frame
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

Time frame
At 3 and 6 months postoperatively.

Other outcomes

1

Use of co-analgesia

Number of treatments used and frequency of use (lidocaine-ketamine cream, NSAIDs, gabapentinoids, etc.)

Time frame
Assessed once daily total co-analgesic doses administered, until discharge (an average of 7 days), up to 60 days.
2

Postoperative quality of life

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."

Time frame
At 3 and 6 months postoperatively
3

Opioid use

Opioid use at 3 and 6 months postoperatively, assessed by the presence or absence of opioid use and the type of opioid used.

Time frame
At 3 and 6 months postoperatively

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