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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 December 2017 |
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Main ID: |
NCT02302586 |
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Date of registration:
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20/11/2014 |
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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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Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)
VATS |
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Scientific title:
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Effects of Thoracic Paravertebral Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS) - A Randomized, Clinical Trial |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02302586 |
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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: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Mert N Senturk, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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MD, Prof |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
ASA I-III Patients who undergo Video-assisted thoracoscopic surgery (VATS) under GA
Exclusion Criteria:
Patients with difficult understanding the instructions for using PCA and/or pain scales
Patients with contraindication to regional anesthesia Patients with significant neurologic,
psychiatric or cognitive disorders History of substance abuse or chronic opioid use
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pain, Postoperative
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Intervention(s)
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Drug: Thoracic paravertebral block (TPVB)
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Drug: Patient Controlled Analgesia (IV PCA)
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Primary Outcome(s)
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Postoperative chronic pain scores (VAS) at rest and during mobilization
[Time Frame: Up to 6 months]
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Secondary Outcome(s)
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Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up
[Time Frame: Up to 6 months]
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Postoperative morphine consumption
[Time Frame: 0-48 hours]
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Time to first analgesic
[Time Frame: 0-48 hours]
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Postoperative nausea and vomiting (PONV) and antiemetic requirements
[Time Frame: 0-48 hours]
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Postoperative first oral intake, flatulence, defecation, mobilization times
[Time Frame: 0-48 hours]
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Postoperative acute pain at rest and during coughing/mobilization
[Time Frame: 0-48 hours]
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Postoperative hospital discharge day and time
[Time Frame: Participants is being followed for the duration of hospital stay, an expected average of 1 week]
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Postoperative vital signs
[Time Frame: 0-48 hours]
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Secondary ID(s)
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46143867-1035
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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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