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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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16 May 2022 |
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Main ID: |
NCT03137576 |
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Date of registration:
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28/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Erector Spinae Plane Block Versus Paravertebral Block During Non-intubated Thoracoscopic Lung Resections.
PABATS |
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Scientific title:
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Pain Blocks in Awake Thoracic Surgery: A Randomized Prospective Trial to Test the Non-inferiority of Erector Spinae Plane Block (ESPB) in Comparison With Paravertebral Block During Non-intubate, Thoracoscopic Lung Resection. |
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Date of first enrolment:
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February 22, 2019 |
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Target sample size:
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7 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03137576 |
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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: Treatment. Masking: Double (Participant, Care Provider).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Wedge Resection of pulmonary nodules performed with a two-portal or three-portal VATS
approach.
Peripheral (within 3 cm from the surface of the inflated lung) nodules, less than 2 cm in
diameter.
Acceptance of awake VATS with written informed consent
Exclusion Criteria:
Age < 18 years
Patients who are pregnant or lactating
Morbid obesity (BMI > 35 )
Inability to understand and sign the Informed consent
Proven allergy to local anesthetic drugs as required by this protocol
Expected pleural adhesions (previous thoracic trauma, previous pleuro-pulmonary infection,
redo surgery on the affected side)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lung Neoplasms
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Intervention(s)
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Procedure: Paravertebral Block (PVB)
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Procedure: Erector Spinae Plane Block (ESPB)
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Primary Outcome(s)
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Dose Escalation of systemic anesthetics during the procedure
[Time Frame: 1 hour from the end of the procedure]
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Secondary Outcome(s)
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Post operative pain management
[Time Frame: 8, 16, 24 hours from the end of procedure]
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Post operative pain perception
[Time Frame: 8, 16, 24 hours from the end of procedure]
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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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