Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery

NCT05191745 | Completed Phase 3

• 1 other identifier: 2022-3125
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery.

Conditions

Coronary Artery Bypass Graft Surgery

Keywords

Cardiac surgery; Pain

Outcome Measures

Primary Outcomes (1)

• Pain with inspirometry at 24 hours after surgery

  Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"

  24 hours after surgery

Secondary Outcomes (10)

• Opioid consumption

  12, 24 and 48 hours after surgery

• Amount of rescue analgesia administered

  Total in the first 48 hours after surgery

• Pain score at rest

  12, 24 and 48 hours after surgery

• Pain score with inspirometry

  12 and 48 hours after surgery

• Intensive Care Unit (ICU) Length of Stay

  From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study

Other Outcomes (9)

• Presence of postoperative vomiting

  first 48 hours after surgery

• Incidence of bradycardia

  first 48 hours after surgery

• Incidence of hyperglycemia

  first 48 hours after surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients will receive bilateral parasternal blocks at the end of cardiac surgery.

Drug: Parasternal blocks

Control group

PLACEBO COMPARATOR

Patients will receive all standard care as per the hospital protocols.

Drug: Standard of care

Interventions

Parasternal blocks DRUG

Parasternal block with Bupivacaine 0.25% + Epinephrine 1:200,000 x 60cc + Dexamethasone 5mg and Dexmedetomidine 50mcg

Also known as: pecto-intercostal fascial blocks

Intervention group

Standard of care DRUG

All standard management of postoperative pain, as per local protocols

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients coming for elective and urgent coronary artery bypass (CABG)-only surgery.

You may not qualify if:

• Patients with a history of regular opioid use.
• Patients with a history of chronic pain.
• Patients unable to provide consent.

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Related Publications (1)

• Cameron MJ, Long J, Yang SS, Kardash K. How Many Patients Are Needed to Detect a Difference in Pain With Parasternal Blocks? Anesth Analg. 2025 Jul 1;141(1):210-211. doi: 10.1213/ANE.0000000000007355. Epub 2024 Dec 17. No abstract available.

  PMID: 39689005 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 13, 2022
• Study Start: January 26, 2022
• Primary Completion: April 28, 2023
• Study Completion: June 1, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

CA (1)