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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: |
NCT02537860 |
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Date of registration:
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25/08/2015 |
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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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Paravertebral Block for Inguinal Hernia Repair in Elderly
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Scientific title:
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Paravertebral Block for Inguinal Hernia Repair in Elderly: Randomized Double-blinded Clinical Trial |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02537860 |
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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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Zoher Naja |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chairperson of Anesthesia department |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients admitted to undergo elective unilateral inguinal hernia repair
- patients with ASA II, III or IV
Exclusion Criteria:
- bilateral inguinal hernia
- incarcerated hernia
- emergency cases
- known history of allergic reactions to local anesthesia
- bleeding disorders
- neurological disorders
- infection at site of injection
Age minimum:
65 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Inguinal Hernia Repair
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Intervention(s)
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Other: Paravertebral block injections from T12 to L2
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Drug: Intravenous (IV) fentanyl
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Other: Placebo at T11 and L3
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Procedure: Herniorrhaphy
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Drug: Bupivacaine
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Other: Paravertebral block injections between T11 and L3
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Primary Outcome(s)
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Mean arterial pressure (MAP) for hemodynamic stability
[Time Frame: Patients will be monitored during the operation, an expected average of 90 minutes]
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Secondary Outcome(s)
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Pain assessed through the Verbal Numeric Rating Scale (VNRS).
[Time Frame: 5 postoperative days]
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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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