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

Phase 3Not Yet RecruitingNCT07732465

Montreal Heart Institute120 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

120

Conditions

Coronary Artery Bypass Grafting (CABG) Surgery Saphenectomy

Interventions

Aductor canal blocPROCEDURE

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

Control adductor canal blockPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Locations (1)

Montreal Heart Institute

Montreal, Quebec, Canada

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

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

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

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.

Persistent Postoperative Pain

Central Contacts

Christian Ayoub, MD

CONTACT

5147088999 ayoub_christian@hotmail.com

Data from ClinicalTrials.gov

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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.

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.

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

Time frame: Numeric rating scale at 3 and 6 months.

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

Time frame: At 48 hours, 3 months, and 6 months.

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.

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

Opioid-related side effects

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

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.

Time to extubation

Time to extubation after adductor canal block

Time frame: At extubation