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Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608126
First Posted: May 30, 2012
Last Update Posted: May 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Nalos MD, Masaryk Hospital Krajská zdravotní a.s.
  Purpose

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.


Condition Intervention
Cervical Plexus Block Comparison Procedure: cervical block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Comparison of Medial Cervical Plexus Block Versus Combined (Superficial and Deep) Cervical Plexus Block for Carotid Endarterectomy: A Prospective, Randomized Single Blind Study

Further study details as provided by Daniel Nalos MD, Masaryk Hospital Krajská zdravotní a.s.:

Primary Outcome Measures:
  • 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

  • patient satisfaction [ Time Frame: 24 h after operation ]
  • Complications [ Time Frame: perioperative ]

Enrollment: 100
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing Elective Carotid Endarterectomy

Exclusion Criteria:

  • Denied consent to block performance, Emergency procedure
  Contacts and Locations
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): NCT01608126


Locations
Czech Republic
Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
Ústí nad Labem, Czech Republic, 401 13
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: Daniel Nalos MD, Prim Daniel Nalos, MUDr., Head of Dept., Anaesthesiology and Critical Care, Masaryk Hospital Krajská zdravotní a.s.
ClinicalTrials.gov Identifier: NCT01608126     History of Changes
Other Study ID Numbers: Medial block II /nalos
First Submitted: May 25, 2012
First Posted: May 30, 2012
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Daniel Nalos MD, Masaryk Hospital Krajská zdravotní a.s.:
Ultrasound
Cervical Plexus
Anesthesia, Conduction
Surgical Procedures, Elective
Atherectomy


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