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TAVI Protocol - Paravertebral Block Study (TAVI PVB)

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ClinicalTrials.gov Identifier: NCT01404975
Recruitment Status : Recruiting
First Posted : July 28, 2011
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Aortic Valve Replacement Aortic Stenosis Other: Thoracic paravertebral block (PVB) Phase 4

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Delirium After Trans-Apical Aortic Valve Replacement (TAVI): A Multifaceted Approach of Perioperative Care
Study Start Date : June 2011
Primary Completion Date : August 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Paravertebral Block
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)

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 Name: PCA, PVT, PVB, TAVI
Active Comparator: Standard intravenous opioid analgesia

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)

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 Name: PCA, PVT, PVB, TAVI


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Hospital length of stay [ Time Frame: 2 years ]
  2. Total cost will be compared between the two groups. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404975


Contacts
Contact: George Djaiani, MD 416 340-4800 ext 6205 george.djaiani@uhn.on.ca
Contact: Jo Carroll, BHA 416 340-4800 ext 3243 jo.carroll@uhn.ca

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Principal Investigator: George Djaiani, MD, FRCP         
Sponsors and Collaborators
University Health Network, Toronto
More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01404975     History of Changes
Other Study ID Numbers: UHN REB #: 11-0260-B
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016

Keywords provided by University Health Network, Toronto:
Delirium
PVB
PCA
Opioid
Aortic Valve replacement

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction