TAVI Protocol - Paravertebral Block Study

NCT01404975 | Completed DMC

• 1 other identifier: UHN REB #: 11-0260-B
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Trans-apical aortic valve replacement is a new treatment for severe aortic stenosis. It is offered to elderly patients with medical problems that would markedly increase the risk of conventional cardiac surgery. The rate of delirium (acute confusional state) after surgery in these patients may exceed 50%. Estimated hospital costs associated with delirium at Toronto General Hospital last year exceeded $1-million CAD. Pain after surgery and the use of opioids (morphine type of pain-relief drugs) are known to increase the risk of delirium. The investigators plan to minimize the use of opioids and improve pain management by replacing the standard intravenous opioid-based pain management with the paravertebral nerve block using only the local anesthetic. These two management strategies will be compared with respect to the rate of delirium, duration of hospital stay, and the overall costs. Hypothesis: Paravertebral analgesia with LA decreases the incidence of delirium after trans-apical AVR when compared to standard systemic opioid-based analgesia.

Conditions

Aortic Valve Replacement; Aortic Stenosis

Keywords

Delirium; PVB; PCA; Opioid; Aortic Valve replacement

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Dichotomous outcome,number of patients with delirium in the two study groups.

  The primary objective is to determine if paravertebral analgesia with local anesthetic (LA) reduces the incidence of delirium after trans-apical AVR.

  2 years

Secondary Outcomes (2)

• Hospital length of stay

  2 years

• Total cost will be compared between the two groups.

  2 years

Study Arms (2)

Paravertebral Block

EXPERIMENTAL

Patients randomized to receive PVB will have a continuous thoracic paravertebral block using local anesthetic after trans-apical aortic valve replacement. The patient will be placed in lateral decubitus position and under aseptic conditions the skin entry points will be 2.5-3cm from the spinal processes of the vertebra at a level of the proposed surgical incision. A 17G Touhy needle will be inserted perpendicular to the skin until the transverse process is contacted. After negative aspiration test an initial bolus of 8ml of plain ropivacaine 0.5% will be administered. This will be followed by a continuous infusion of 0.2% ropivacaine at 10 mL/hr. For break through pain additional doses of ropivacaine will be administered as required.

Other: Thoracic paravertebral block (PVB)

Standard intravenous opioid analgesia

ACTIVE COMPARATOR

Patient Controlled Analgesia (PCA) : PCA: the patients who are randomized to PCA group will receive standard of care for this modality.

Other: Thoracic paravertebral block (PVB)

Interventions

Thoracic paravertebral block (PVB) OTHER

We are planning to replace the standard intravenous opioid analgesia with a continuous paravertebral block using local anesthetic after trans-apical aortic valve replacement. Anesthesia management will be standardized to minimize any impact that anesthetic type may have on neurological outcomes. Adjuvant supplemental analgesia will be provided to both groups according to the standardized institutional guidelines.

Also known as: PCA, PVT, PVB, TAVI

Paravertebral Block; Standard intravenous opioid analgesia

Eligibility Criteria

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

You may qualify if:

• Consenting subjects who are scheduled to undergo the TAVI surgical procedure

You may not qualify if:

• patients with symptomatic cerebrovascular disease,
• history of delirium and schizophrenia

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Delirium

Interventions

Passive Cutaneous Anaphylaxis; PVB protocol; Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: July 28, 2011
• Study Start: June 1, 2011
• Primary Completion: June 10, 2016
• Study Completion: August 1, 2016
• Last Updated: April 17, 2018

Record last verified: 2018-01

Locations

CA (1)