Trial record 8 of 229 for:    aortic valve replacement

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
  Purpose

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 Intervention Phase
Aortic Valve Replacement
Aortic Stenosis
Other: Thoracic paravertebral block (PVB)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Delirium After Trans-Apical Aortic Valve Replacement (TAVI): A Multifaceted Approach of Perioperative Care

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 116
Study Start Date: June 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404975

Contacts
Contact: Jo Carroll, BHA 416 340-4800 ext 3243 jo.carroll@uhn.on.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

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01404975     History of Changes
Other Study ID Numbers: UHN REB #: 11-0260-B
Study First Received: June 21, 2011
Last Updated: November 25, 2013
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on October 30, 2014