Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method
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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 |
- 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 |
Inclusion Criteria:
- Patients undergoing Elective Carotid Endarterectomy
Exclusion Criteria:
- Denied consent to block performance, Emergency procedure
Contacts and Locations| Czech Republic | |
| Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z. | |
| Ústí nad Labem, Czech Republic, 401 13 | |
| 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 May 19, 2013