Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method

NCT ID: NCT01608126

Last Updated: 2012-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Plexus Block Comparison

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Combined Cervical Block

Group Type ACTIVE_COMPARATOR

cervical block

Intervention Type PROCEDURE

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).

Median Cervical Block US guided

Group Type ACTIVE_COMPARATOR

cervical block

Intervention Type PROCEDURE

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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing Elective Carotid Endarterectomy

Exclusion Criteria

* Denied consent to block performance, Emergency procedure
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daniel Nalos MD

OTHER

Sponsor Role lead

Responsible Party

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Daniel Nalos MD

Prim Daniel Nalos, MUDr., Head of Dept., Anaesthesiology and Critical Care

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Daniel Nalos, MUDr.

Role: STUDY_CHAIR

Masaryk Hospital

Jiří Cihlář, Prof Ing

Role: PRINCIPAL_INVESTIGATOR

Purkynje University Ústí nad Labem

Luděk Vašátko, MUDr.

Role: PRINCIPAL_INVESTIGATOR

Masaryk Hospital

David Bejšovec, MUDr.

Role: PRINCIPAL_INVESTIGATOR

Masaryk Hospital

Locations

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Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.

Ústí nad Labem, , Czechia

Site Status

Countries

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Czechia

References

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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. doi: 10.1093/bja/aem160. Epub 2007 Jun 18.

Reference Type BACKGROUND
PMID: 17576970 (View on PubMed)

Hakl M, Michalek P, Sevcik P, Pavlikova J, Stern M. Regional anaesthesia for carotid endarterectomy: an audit over 10 years. Br J Anaesth. 2007 Sep;99(3):415-20. doi: 10.1093/bja/aem171. Epub 2007 Jul 9.

Reference Type BACKGROUND
PMID: 17621600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21613278 (View on PubMed)

Other Identifiers

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Medial block II /nalos

Identifier Type: -

Identifier Source: org_study_id

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