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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03061292 |
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Date of registration:
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14/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cardiac Implantable Electronic Device Implantation With and Without Pectoral Nerve Block
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Scientific title:
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A Randomized, Controlled Trial on Patients Undergoing Cardiac Implantable Electronic Device Implantation With Local Anaesthesia and Sedation With and Without Pectoral Nerve Block |
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Date of first enrolment:
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July 25, 2016 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03061292 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other.
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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CTRU |
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Address:
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Telephone:
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67888833 |
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Email:
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Affiliation:
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Name:
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Vern Hsen Tan, MBBS |
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Address:
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Telephone:
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Email:
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vern_hsen_tan@cgh.com.sg |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Fulfilled the indication for CIED implantation as defined in 2008 guidelines for
device-based therapy of cardiac rhythm abnormalities
Exclusion Criteria:
- Pregnant
- Those who receives subcutaneous implantable cardioverter defibrillator
- Vulnerable subjects (children, prisoners, cognitive impaired persons)
- Known history of allergy to local anaesthetic medications
Age minimum:
21 Years
Age maximum:
95 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiac IED Implantation
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Intervention(s)
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Procedure: Without Pectoral Nerve Block
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Procedure: Pectoral Nerve Block
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Primary Outcome(s)
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Perioperative sedation scores
[Time Frame: 2 years]
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Perioperative pain scores
[Time Frame: 2 years]
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Total dose of sedation used
[Time Frame: 2 years]
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Incidence of hypoxia, hypotension and hypopnea in the perioperative period
[Time Frame: 2 years]
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Post-anaesthetic discharge score
[Time Frame: 2 years]
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Secondary Outcome(s)
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Patient satisfaction scores
[Time Frame: 2 years]
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Procedurist satisfaction scores
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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