Recruiting

Paravertebral Block

Sponsor:

University of British Columbia

Code:

NCT06008821

Conditions

Post-operative Pain

Post-cardiac Surgery

Cardiac Disease

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

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

Bilateral sham block with normal saline

Study Details

Brief 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

Study ID

NCT06008821

Start date

Oct 13, 2023

Status verified date

Aug, 2023

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

Bilateral, single level, paravertebral blockade with 0.25% ropivicaine

sham comparator: Control Group

Bilateral, single level, subcutaneous sham block with normal saline

Interventions

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)

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)

Primary outcome measure

  • Initial Quality of Recover-15 (QoR-15) score [ Time Frame: 24 hours following the intervention ]

Central Contacts and Locations

Central contacts

Terri Sun, M.D.

604-779-7817terri.sun@gmail.com

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Terri Sun, M.D.

604-779-7817terri.sun@gmail.com

More Information

Sponsor

University of British Columbia

Last update posted

Jan 8, 2024

Last verified

Aug, 2023

Keywords

  • Regional anesthesia
  • Paravertebral blockade
  • Cardiac surgery
  • Post-operative pain
  • Quality of recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-01-08.