Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method

May 29, 2012 updated by: Daniel Nalos MD

A Comparison of Medial Cervical Plexus Block Versus Combined (Superficial and Deep) Cervical Plexus Block for Carotid Endarterectomy: A Prospective, Randomized Single Blind Study

The purpose of the study is to compare efficacy, complications and safety of the standard method of Combined (superficial and deep) cervical plexus block (SDCPB) with Ultrasound guided Medial Cervical plexus block technique (MCPB).

Hypothesis: Ultrasound assisted MCPB is safer than SDCPB with similar efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ústí nad Labem, Czech Republic, 401 13
        • Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing Elective Carotid Endarterectomy

Exclusion Criteria:

  • Denied consent to block performance, Emergency procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Combined Cervical Block
Procedure: cervical block

In brief, the superficial block was performed using a 22G needle (07 x 40 mm). The mixture injected was 15 ml of 0.5% bupivacaine + 10 ml of 1% lidocaine. Deep cervical plexus block was performed using a Stimuplex DR stimulating needle and the dose of anaesthetic used was 10 ml 0.5% bupivacaine + 5 ml 1% lidocaine applied in the vicinity of the C3 nerve root.

The MCPB performed using ultrasound-guidance aiming specifically for the interfascia space. Eighteen ml of 0.375% bupivacaine was injected into the interfascia space at the level of C3 vertebral body using a 22G needle (07 x 40 mm).
Active Comparator: Median Cervical Block US guided
Procedure: cervical block

In brief, the superficial block was performed using a 22G needle (07 x 40 mm). The mixture injected was 15 ml of 0.5% bupivacaine + 10 ml of 1% lidocaine. Deep cervical plexus block was performed using a Stimuplex DR stimulating needle and the dose of anaesthetic used was 10 ml 0.5% bupivacaine + 5 ml 1% lidocaine applied in the vicinity of the C3 nerve root.

The MCPB performed using ultrasound-guidance aiming specifically for the interfascia space. Eighteen ml of 0.375% bupivacaine was injected into the interfascia space at the level of C3 vertebral body using a 22G needle (07 x 40 mm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of additional applications of short-acting local anaesthetic
Time Frame: intraoperatively
The number of times a surgeon would have to supplement the Regional Block with intrafield application of increments of short-acting local anaesthetic
intraoperatively
patient satisfaction
Time Frame: 24 h after operation
24 h after operation
Complications
Time Frame: perioperative
perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Nalos MD

Investigators

  • Study Chair: Daniel Nalos, MUDr., Masaryk Hospital
  • Principal Investigator: Jiří Cihlář, Prof Ing, Purkynje University Ústí nad Labem
  • Principal Investigator: Luděk Vašátko, MUDr., Masaryk Hospital
  • Principal Investigator: David Bejšovec, MUDr., Masaryk Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 29, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Medial block II /nalos

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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