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Paravertebral Block for Improvement of Quality of Recovery Following Cardiac Surgery

NCT06008821 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2024-01-08

No results posted yet for this study

Summary

This study aims to evaluate the efficacy of bilateral, paravertebral blockade (intervention) against sham blocks (control) placed prior to sternotomy in improving quality of recovery following cardiac surgery.

Primary outcome: The hypothesis is that bilateral single-shot PVB at the thoracic spinal segmental levels T3/4, compared with sham blocks, improve the Quality of Recovery-15 (QoR-15) score at 24 hours following cardiac surgery by a minimally clinically important difference of 8.0 or greater.

Secondary outcomes: The hypothesis is that the intervention will reduce pain scores, opioid requirements, and related side effects; improve respiratory mechanics; and facilitate a better first night's rest/sleep in the first 24-48 hours compared to sham blocks.

Conditions

  • Post-operative Pain
  • Post-cardiac Surgery
  • Cardiac Disease

Interventions

PROCEDURE

Bilateral paravertebral block with 0.25% ropivicaine with 1:400,000 epinephrine

60mL of 0.25% ropivacaine will be injected into the PVB at thoracic vertebrae T3/4 level bilaterally (30mL at each site for a total of 2 injections)

PROCEDURE

Bilateral sham block with normal saline

10 mL of normal saline will be injected into subcutaneous space at the T3/4 level bilaterally (5 mL at each site for a total of 2 injections)

Sponsors & Collaborators

  • Providence Health & Services

    collaborator OTHER

  • Canadian Anesthesiologists' Society

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Terri Sun, M.D. · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-13
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06008821 on ClinicalTrials.gov