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Paravertebral Block for Improvement of Quality of Recovery Following Cardiac Surgery

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

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    19 and up

Participation Criteria

Inclusion Criteria

* All adult (19 years or older)
* English-speaking patients
* Scheduled for elective cardiac surgery with full median sternotomy.

Exclusion Criteria

* Patient refusal, inability to provide consent
* Mini-Cog© Score of 1-2
* emergent surgery
* infection at the site of injection
* empyema
* neoplastic mass in the paravertebral space
* known preoperative coagulopathy
* platelet count \< 50 x 109, INR or aPTT exceeding the upper range of normal in the absence of anticoagulant use, patients receiving anticoagulation medications or non-ASA anti-platelet medications that have not been stopped for the appropriate duration in accordance with American Society of Regional Anesthesia and Pain Medicine guidelines (20)
* severe kyphoscoliosis or deformed spines or previous thoracic surgery
* allergy to study medications
* preoperative liver failure (as defined by Child-Pugh B or C)
* chronic pain or opioid use history, alcohol or drug use disorders, major psychiatric or neurodevelopmental disorders
* Moderate to severe pain at baseline.
* preoperative renal failure (as defined by eGFR \< 30 mL/min/1.73 m2)
* extremes of weight (BMI \> 40 kg/m2, and weight \< 50 kg)
* Patients anticipated to require prolonged post-operative ventilation \> 24 hours after surgery

* High risk by Euroscore II \>=8%) (21-23)
* 3 or more major procedures
* Procedures requiring deep hypothermic circulatory arrest (DHCA)

Study Location

St. Paul's Hospital
St. Paul's Hospital
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Terri Sun, M.D.

[email protected]
604-779-7817
Study Sponsored By
University of British Columbia
Participants Required
More Information
Study ID: NCT06008821