PVB With vs. Without Clonidine for Ventral Hernia Repair
Primary Purpose
Ventral Hernia Repair
Status
Suspended
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Clonidine
Placebo
Sponsored by
About this trial
This is an interventional other trial for Ventral Hernia Repair focused on measuring clonidine, paravertebral block, hemodynamic stability
Eligibility 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
Sites / Locations
- Makassed General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Clonidine
Placebo
Arm Description
Will receive bilateral PVB with clonidine.
Will receive bilateral PVB with placebo.
Outcomes
Primary Outcome Measures
Hemodynamic stability recorded from electrocardiogram and pulse oximeter
Compare the hemodynamic stability between the two groups
Secondary Outcome Measures
Postoperative nausea and vomiting recorded via questionnaire
Comparison of postoperative nausea and vomiting between the two groups
Postoperative analgesic consumption recorded via questionnaire
Comparison of analgesic consumption between the two groups
Full Information
NCT ID
NCT02505204
First Posted
July 20, 2015
Last Updated
January 14, 2022
Sponsor
Makassed General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02505204
Brief Title
PVB With vs. Without Clonidine for Ventral Hernia Repair
Official Title
Paravertebral Block With Versus Without Clonidine for Patients Undergoing Ventral Hernia Repair: A Prospective Double-blinded Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Suspended
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia Repair
Keywords
clonidine, paravertebral block, hemodynamic stability
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clonidine
Arm Type
Experimental
Arm Description
Will receive bilateral PVB with clonidine.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Will receive bilateral PVB with placebo.
Intervention Type
Other
Intervention Name(s)
Clonidine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
the same anesthetic mixture will be administrated however the clonidine will be substituted with 2 mL saline.
Primary Outcome Measure Information:
Title
Hemodynamic stability recorded from electrocardiogram and pulse oximeter
Description
Compare the hemodynamic stability between the two groups
Time Frame
within the first 48 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting recorded via questionnaire
Description
Comparison of postoperative nausea and vomiting between the two groups
Time Frame
within the first 48 hours after surgery
Title
Postoperative analgesic consumption recorded via questionnaire
Description
Comparison of analgesic consumption between the two groups
Time Frame
within the first 48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoher Naja, MD
Organizational Affiliation
Chairperson of Anesthesia department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
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PVB With vs. Without Clonidine for Ventral Hernia Repair
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