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TAVI Protocol - Paravertebral Block Study (TAVI PVB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01404975
First received: June 21, 2011
Last updated: November 25, 2013
Last verified: November 2013

June 21, 2011
November 25, 2013
June 2011
December 2013   (final data collection date for primary outcome measure)
Primary Outcome: Dichotomous outcome,number of patients with delirium in the two study groups. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
The primary objective is to determine if paravertebral analgesia with local anesthetic (LA) reduces the incidence of delirium after trans-apical AVR.
Same as current
Complete list of historical versions of study NCT01404975 on ClinicalTrials.gov Archive Site
  • Hospital length of stay [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Total cost will be compared between the two groups. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary outcome: Hospital length of stay and the total cost will be compared between the two groups. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The secondary objective is to identify if the hospital length of stay and the overall costs are reduced with the new treatment modality.
Not Provided
Not Provided
 
TAVI Protocol - Paravertebral Block Study
Reducing Delirium After Trans-Apical Aortic Valve Replacement (TAVI): A Multifaceted Approach of Perioperative Care

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Valve Replacement
  • Aortic Stenosis
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
  • 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.
    Intervention: Other: Thoracic paravertebral block (PVB)
  • 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.

    Intervention: Other: Thoracic paravertebral block (PVB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
116
July 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jo Carroll, BHA 416 340-4800 ext 3243 jo.carroll@uhn.on.ca
Canada
 
NCT01404975
UHN REB #: 11-0260-B
Yes
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Not Provided
University Health Network, Toronto
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP