PVB With vs. Without Clonidine for Ventral Hernia Repair
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|ClinicalTrials.gov Identifier: NCT02505204|
Recruitment Status : Suspended
First Posted : July 22, 2015
Last Update Posted : January 18, 2022
Paravertebral block (PVB) combined with light intravenous sedation was associated with a short hospital stay, less post-operative nausea and vomiting and reduced analgesic consumption compared to general anesthesia for ventral hernia repair. Given the effectiveness of PVB in the ventral hernia repair, it would be beneficial to study the effect of PVB with versus without clonidine in elderly patients.
Patients will be randomly allocated to one of 2 groups with 30 patients in each, using the sealed envelope technique. Group one will receive PVB with clonidine while group 2 will receive PVB with placebo.
|Condition or disease||Intervention/treatment||Phase|
|Ventral Hernia Repair||Other: Clonidine Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Paravertebral Block With Versus Without Clonidine for Patients Undergoing Ventral Hernia Repair: A Prospective Double-blinded Randomized Study|
|Actual Study Start Date :||August 1, 2015|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Will receive bilateral PVB with clonidine.
The anesthetic mixture will contain: lidocaine 2% 7 mL, lidocaine 2% 6 mL with epinephrine 5µg.mL-1, bupivacaine 0.5% 5 mL, and clonidine 2 mL.
Placebo Comparator: Placebo
Will receive bilateral PVB with placebo.
the same anesthetic mixture will be administrated however the clonidine will be substituted with 2 mL saline.
- Hemodynamic stability recorded from electrocardiogram and pulse oximeter [ Time Frame: within the first 48 hours after surgery ]Compare the hemodynamic stability between the two groups
- Postoperative nausea and vomiting recorded via questionnaire [ Time Frame: within the first 48 hours after surgery ]Comparison of postoperative nausea and vomiting between the two groups
- Postoperative analgesic consumption recorded via questionnaire [ Time Frame: within the first 48 hours after surgery ]Comparison of analgesic consumption between the two groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505204
|Makassed General Hospital|
|Principal Investigator:||Zoher Naja, MD||Chairperson of Anesthesia department|