PVB With vs. Without Clonidine for Ventral Hernia Repair

• ClinicalTrials.gov Identifier: NCT02505204
• Recruitment Status: Suspended
• First Posted: July 22, 2015
• Last Update Posted: January 19, 2021
• Sponsor: Makassed General Hospital
• Information provided by (Responsible Party): Zoher Naja, Makassed General Hospital

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.

Condition or disease	Intervention/treatment	Phase
Ventral Hernia Repair	Other: Clonidine; Other: Placebo	Not Applicable

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.

Study Design

• 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: April 2021
• Estimated Study Completion Date: April 2021

Arms and Interventions

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

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

• 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

Locations

Lebanon

Makassed General Hospital

Beirut, Lebanon

Sponsors and Collaborators

Makassed General Hospital

Investigators

• Principal Investigator: Zoher Naja, MD; Chairperson of Anesthesia department

More Information

• Responsible Party: Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital
• ClinicalTrials.gov Identifier: NCT02505204
• Other Study ID Numbers: 07/09/2015
• First Posted: July 22, 2015
• Last Update Posted: January 19, 2021
• Last Verified: January 2021

Keywords provided by Zoher Naja, Makassed General Hospital:

clonidine; paravertebral block; hemodynamic stability

Additional relevant MeSH terms:

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