Paravertebral Block for Improvement of Quality of Recovery Following Cardiac Surgery

NCT06008821 | Unknown DMC

• 1 other identifier: H23-00055
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Initial Quality of Recover-15 (QoR-15) score

  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.

  24 hours following the intervention

Secondary Outcomes (12)

• Subsequent Quality of Recovery-15 (QoR-15) scores

  48 hours following surgery and 12 weeks following surgery

• Quality of sleep

  24 hours and 48 hours following surgery

• Opioid consumption

  24 hours and 48 hours following surgery

• Pain scores

  every 4 hours for the first 24 hours then every 8 hours until the 48 hour mark following surgery

• Severity of post-operative nausea and vomiting

  24 hours and 48 hours following surgery.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Bilateral, single level, paravertebral blockade with 0.25% ropivicaine

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

Control Group

SHAM COMPARATOR

Bilateral, single level, subcutaneous sham block with normal saline

Procedure: Bilateral sham block with normal saline

Interventions

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

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)

Intervention Group

Bilateral sham block with normal saline PROCEDURE

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)

Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Providence Health & Services: collaborator
• Canadian Anesthesiologists' Society: collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Heart Diseases

Interventions

Epinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Terri Sun, M.D.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terri Sun, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study observes blinding of the patients, anesthesiologists, surgeons, nurses, outcome collectors, and data analysts. Only the regional anesthesiologist performing the intervention will be unblinded. To maintain the quality and legitimacy of the trial, unblinding may only occur if knowledge of the actual intervention is essential to treat and manage the patient. In events such as acute and limited episode of hypotension or bradycardia from a vasovagal event, blinding will be maintained as knowledge of intervention is not required for management. All code breaks with reason will be documented and reported. A protocol description of conditions and procedures for emergency unblinding will be drafted, but the ultimate decision at the time of the block will be at the discretion of the regional anesthesiologist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: This will be a triple-blinded (patient, outcomes assessor and all clinicians except the regional anesthesiologist), individually-randomized, placebo-controlled trial in which patients will be randomly allocated to two study groups in a 1:1 ratio. We will randomize patients in blocks of 4 or 6.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 24, 2023
• Study Start: October 13, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 8, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)