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Trial record 20 of 328 for:    clonidine

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

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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Detailed Description:

Introduction

Paravertebral block (PVB) showed to be successful in both children and adults. It has been reported to be an excellent pain reliever and it reduces post-operative nausea and vomiting, in patients undergoing breast surgery. PVB has proven to be very useful as a regional anesthetic technique when it comes to surgeries involving lumbar and thoracic dermatome. It was shown that the PVB combined with light intravenous sedation was associated with a short hospital stay, less post-operative nausea and vomiting (PONV) 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.

Objectives:

The primary objective of this study is to compare the hemodynamic stability in a ventral hernia repair using paravertebral block with clonidine versus the PVB without clonidine.

The secondary objectives include a comparison of PONV and postoperative analgesic consumption.

Materials and Methods

Study design and sampling This is a prospective study with a randomized double- blinded design that will be conducted between August 2015 and August 2016.

Patients scheduled for ventral hernia repair whose age is 65 years and older with American Society of Anesthesiologists (ASA) greater or equal to 2 will be included. Exclusion criteria comprised history of allergic reactions to local anesthetics, bleeding diatheses and spinal abnormality.

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.

Anesthetic techniques Since this trial is double-blinded, a specialized nurse will prepare the syringes for each patient.

Paravertebral nerve block techniques Bilateral nerve-stimulator PVB will be performed at the levels of T9-T10 or T9-T11 according to the type of ventral hernia and the planned incision type. The patient will be anesthetized in the lateral decubitus position. Supplemental oxygen will be given by facemask and regular anesthetic monitors will be attached.

Each local anesthetic mixture will contain:

For group 1, the syringes will contain: lidocaine 2% 6 mL, lidocaine 2% 6 mL with epinephrine 5µg.mL-1, bupivacaine 0.5% 5 mL, fentanyl 1 mL (50µg) and clonidine 2 mL.

As for the group 2, the same anesthetic mixture will be administrated however the clonidine will be substituted with 2 mL saline.

Data collection

Demographic data, ASA score, type and duration of surgery will be recorded. Haemodynamics will be registered such as the mean arterial blood pressure, heart rate and oxygen saturation, preoperatively (baseline), intra-operatively (incision of skin, dissection of hernia, traction over the sac and closure of incision) and postoperatively.

As for postoperative analgesia consumption, patients with a VAS score between three and four are given Tramadol Hydrochloride 50-100 mg every 4- 6 hours. If the VAS score is greater or equal to five, patients receive 1 mg/kg Dolosal.

Post-operative nausea and vomiting will be recorded in the recovery room and in the regular ward. Pain assessment will be taken from patients by a verbal statement using Numeric Rating Scale.


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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

Resource links provided by the National Library of Medicine


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.




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



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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

Information from the National Library of Medicine

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

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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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Clonidine
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal
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