About this trial
Adductor Canal Block: Efficacy in Postoperative Pain Management for Cardiac Surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Aductor canal bloc
Procedure/SurgeryAdductor canal bloc with 0,25% bupivacaine + 20 ucg of dexmedetomidine
Control adductor canal block
Procedure/SurgeryNeedle insertion mimicking the ACB procedure with injection of a saline solution
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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).
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
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
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
Other outcomes
Use of co-analgesia
Number of treatments used and frequency of use (lidocaine-ketamine cream, NSAIDs, gabapentinoids, etc.)
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."
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.
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