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NCT Number: NCT01404975

TAVI Protocol - Paravertebral Block Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

About this study

A prospective, randomized, controlled, multicentre study (Toronto General Hospital and Sunnybrook Health Science Centre, Toronto, Canada.) The investigators 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.

Metrics to evaluate outcomes: Assessment of delirium will be performed utilizing the CAM-ICU preoperatively (baseline) and postoperatively every 12 hours or as needed according to the patient's condition during the first 7 postoperative days or until discharge.

The CAM recognizes both, hyperactive and hypoactive, forms of delirium. It includes four-step algorithm and assesses 1) an acute onset of changes or fluctuations in the course of mental status, 2) inattention, 3) disorganized thinking and 4) an altered level of consciousness. The patient is determined to be delirious (CAM positive) if he/she manifests both features 1 and 2, plus either feature 3 or 4.

Primary screening for delirium will be performed by the nursing staff. Diagnose of delirium will be confirmed by the psychiatry consult. Assessment of Sedation and Pain: Standardized according to institutional guidelines.

Cost Calculations: The total cost (summation of direct-variable, direct-fixed, and overhead costs) for each patient will be determined for both study groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: PCA, PVT, PVB, TAVI

Primary outcomes

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

    Time frame: 2 years

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

Secondary outcomes

  1. Hospital length of stay

    Time frame: 2 years

  2. Total cost will be compared between the two groups.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Reducing Delirium After Trans-Apical Aortic Valve Replacement (TAVI): A Multifaceted Approach of Perioperative Care

Acronym: TAVI PVB

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2011
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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