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Bilateral Paravertebral Blockade for Improvement of Quality of Recovery Following Cardiac Surgery (P-QOR): a Randomized Controlled Trial
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.
Details
| Lead sponsor | University of British Columbia |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 224 |
| Start date | 2023-10-13 |
| Completion | 2025-11 |
Conditions
- Post-operative Pain
- Post-cardiac Surgery
- Cardiac Disease
Interventions
- Bilateral paravertebral block with 0.25% ropivicaine with 1:400,000 epinephrine
- Bilateral sham block with normal saline
Primary outcomes
- Initial Quality of Recover-15 (QoR-15) score — 24 hours following the intervention
The QoR-15 score is a validated tool used to assess the quality of recovery at 24 hours. following the intervention. This score ranges from 0 to 150, with higher scores indicating higher quality of recovery.
Countries
Canada