Coronary Artery Bypass Grafting (CABG) Surgery, Saphenectomy
Conditions
Keywords
Adductor canal block, Numeric Rating Scale (NRS), Coronary artery bypass grafting (CABG), Saphenectomy, Postoperative period, Placebo-controlled
Brief summary
Adductor Canal Block: Efficacy in Postoperative Pain Management for Cardiac Surgery
Interventions
PROCEDUREAductor canal bloc
Adductor canal bloc with 0,25% bupivacaine + 20 ucg of dexmedetomidine
PROCEDUREControl adductor canal block
Needle insertion mimicking the ACB procedure with injection of a saline solution
Sponsors
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg Pain at Rest | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption | 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). |
| Postoperative pain unrelated to the saphenous territory | 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 |
| Persistent Postoperative Pain | 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 |
| Overall persistent postoperative pain | 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 |
| Presence of hypoesthesia | 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 |
| Neuropathic characterization | 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 |
| Block safety | 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. |
| Opioid-related side effects | 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. |
| Time to extubation | At extubation | Time to extubation after adductor canal block |
Countries
Canada
Contacts
CONTACTChristian Ayoub, MD
Outcome results
None listed