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NCT01608126 Clinical Trial

Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method

Cervical Plexus Block Comparison Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01608126
Other study ID # Medial block II /nalos
Secondary ID
Status Completed
Phase N/A
First received May 25, 2012
Last updated May 29, 2012
Start date January 2011
Est. completion date December 2011

Study information
Verified date May 2012
Source Masaryk Hospital Krajská zdravotní a.s.
Contact n/a
Is FDA regulated No
Health authority Czech Republic: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients undergoing Elective Carotid Endarterectomy

Exclusion Criteria:

- Denied consent to block performance, Emergency procedure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
Czech Republic Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z. Ústí nad Labem

Sponsors (1)
Lead Sponsor Collaborator
Daniel Nalos MD

Country where clinical trial is conducted

Czech Republic, 

References & Publications (3)

Hakl M, Michalek P, Sevcík P, Pavlíková J, Stern M. Regional anaesthesia for carotid endarterectomy: an audit over 10 years. Br J Anaesth. 2007 Sep;99(3):415-20. Epub 2007 Jul 9. — View Citation

Pandit JJ, Satya-Krishna R, Gration P. Superficial or deep cervical plexus block for carotid endarterectomy: a systematic review of complications. Br J Anaesth. 2007 Aug;99(2):159-69. Epub 2007 Jun 18. Review. — View Citation

Ramachandran SK, Picton P, Shanks A, Dorje P, Pandit JJ. Comparison of intermediate vs subcutaneous cervical plexus block for carotid endarterectomy. Br J Anaesth. 2011 Aug;107(2):157-63. doi: 10.1093/bja/aer118. Epub 2011 May 24. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary number of additional applications of short-acting local anaesthetic The number of times a surgeon would have to supplement the Regional Block with intrafield application of increments of short-acting local anaesthetic intraoperatively No
Primary patient satisfaction 24 h after operation No
Primary Complications perioperative Yes

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