Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Nalos MD, Masaryk Hospital Krajská zdravotní a.s.
ClinicalTrials.gov Identifier:
NCT01608126
First received: May 25, 2012
Last updated: May 29, 2012
Last verified: May 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Masaryk Hospital Krajská zdravotní a.s.:

Primary Outcome Measures:
  • number of additional applications of short-acting local anaesthetic [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing Elective Carotid Endarterectomy

Exclusion Criteria:

  • Denied consent to block performance, Emergency procedure
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 25, 2012
Last Updated: May 29, 2012
Health Authority: Czech Republic: Ethics Committee

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

ClinicalTrials.gov processed this record on October 23, 2014