PVB With vs. Without Clonidine for Ventral Hernia Repair

NCT02505204 | Suspended

• 1 other identifier: 07/09/2015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia Repair

Keywords

clonidine; paravertebral block; hemodynamic stability

Outcome Measures

Primary Outcomes (1)

• Hemodynamic stability recorded from electrocardiogram and pulse oximeter

  Compare the hemodynamic stability between the two groups

  within the first 48 hours after surgery

Secondary Outcomes (2)

• Postoperative nausea and vomiting recorded via questionnaire

  within the first 48 hours after surgery

• Postoperative analgesic consumption recorded via questionnaire

  within the first 48 hours after surgery

Study Arms (2)

Clonidine

EXPERIMENTAL

Will receive bilateral PVB with clonidine.

Other: Clonidine

Placebo

PLACEBO COMPARATOR

Will receive bilateral PVB with placebo.

Other: Placebo

Interventions

Clonidine OTHER

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.

Clonidine

Placebo OTHER

the same anesthetic mixture will be administrated however the clonidine will be substituted with 2 mL saline.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zoher Naja, MD

  Chairperson of Anesthesia department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson of Anesthesia and Pain Management Department

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 22, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

LE (1)