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PVB With vs. Without Clonidine for Ventral Hernia Repair

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ClinicalTrials.gov Identifier: NCT02505204
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Zoher Naja, Makassed General Hospital

Study Description
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Brief Summary:

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

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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 : December 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Clonidine
Will receive bilateral PVB with clonidine.
 Other: 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.
 Other: Placebo
the same anesthetic mixture will be administrated however the clonidine will be substituted with 2 mL saline.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Postoperative analgesic consumption recorded via questionnaire [ Time Frame: within the first 48 hours after surgery ]
    Comparison of analgesic consumption between the two groups


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for ventral hernia repair whose age is 65 years and older
  • and with ASA greater or equal to 2

Exclusion Criteria:

  • History of allergic reactions to local anesthetics
  • Bleeding diatheses
  • Spinal abnormality
Contacts and Locations
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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


Contacts
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Contact: Zoher Naja, MD +9611636000 ext 6405 zouhnaja@yahoo.com

Locations
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Lebanon
Makassed General Hospital Recruiting
Beirut, Lebanon
Contact: Zoher Naja, MD    +9611636000 ext 6405    zouhnaja@yahoo.com   
Sponsors and Collaborators
Makassed General Hospital
Investigators
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Principal Investigator: Zoher Naja, MD Chairperson of Anesthesia department
More Information
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Responsible Party: Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT02505204     History of Changes
Other Study ID Numbers: 07/09/2015
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Keywords provided by Zoher Naja, Makassed General Hospital:
clonidine
paravertebral block
hemodynamic stability
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action