Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery

NCT ID: NCT05191745

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-26

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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This study will randomize patients to either standard pain control protocols or parasternal blocks after coronary artery bypass grafting-only surgery. This study will specifically examine the effectiveness and duration of analgesia of parasternal blocks with local anesthetic adjuncts, Dexamethasone 10mg and Dexmedetomidine 50mcg, added to the local anesthetic mixture

Conditions

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Coronary Artery Bypass Graft Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Parasternal blocks

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Standard of care

Intervention Type DRUG

All standard management of postoperative pain, as per local protocols

Interventions

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Parasternal blocks

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

Intervention Type DRUG

Standard of care

All standard management of postoperative pain, as per local protocols

Intervention Type DRUG

Other Intervention Names

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pecto-intercostal fascial blocks

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with a history of regular opioid use.
* Patients with a history of chronic pain.
* Patients unable to provide consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthew Cameron

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 39689005 (View on PubMed)

Other Identifiers

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2022-3125

Identifier Type: -

Identifier Source: org_study_id

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