Cervical Plexus Block ComparisonNCT01608126
Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method
A study testing cervical block in people with Cervical Plexus Block Comparison, run by Daniel Nalos MD at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Cervical Plexus Block Comparison
- What is being tested?
- cervical block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing Elective Carotid Endarterectomy
Who cannot join
- Denied consent to block performance, Emergency procedure
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
Ústí nad Labem, 401 13
About this study
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
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.
- Conditions
- Cervical Plexus Block Comparison
- Being tested
- cervical block
- Keywords
- Ultrasound, Cervical Plexus, Anesthesia, Conduction, Surgical Procedures, Elective, Atherectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical blockProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Combined Cervical Block | Active comparator | Not described Receives: Procedure: cervical block |
| Median Cervical Block US guided | Active comparator | Not described Receives: Procedure: cervical block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: intraoperatively
patient satisfaction
Measured: 24 h after operation
Complications
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical Plexus Block ComparisonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Nalos MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Nalos MD, Masaryk Hospital Krajská zdravotní a.s.
- Investigators
- Daniel Nalos, MUDr., Study chair, Masaryk HospitalJiří Cihlář, Prof Ing, Principal investigator, Purkynje University Ústí nad LabemLuděk Vašátko, MUDr., Principal investigator, Masaryk HospitalDavid Bejšovec, MUDr., Principal investigator, Masaryk Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608126
- Sponsor's protocol ID
- Medial block II /nalos
- Status last verified
- May 2012
- First submitted
- 25 May 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17576970Hakl 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.
PubMed 17621600Ramachandran 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.
PubMed 21613278
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01608126
- Acronym / sponsor ID
- Medial block II /nalos
- Conditions
- Cervical Plexus Block Comparison
- Keywords
- Ultrasound, Cervical Plexus, Anesthesia, Conduction, Surgical Procedures, Elective, Atherectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Daniel Nalos MDUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Cervical Block | Active comparator | Procedure: cervical block |
| Median Cervical Block US guided | Active comparator | Procedure: cervical block |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing Elective Carotid Endarterectomy
Key exclusion criteria (1 listed)
- Denied consent to block performance, Emergency procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical blockIn 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). | Procedure or surgery | Combined Cervical Block, Median Cervical Block US guided |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
- Background: PubMed 17576970Pandit 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.
- Background: PubMed 17621600Hakl 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.
- Background: PubMed 21613278Ramachandran 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Nalos, MUDr. study chair
Masaryk Hospital
Jiří Cihlář, Prof Ing principal investigator
Purkynje University Ústí nad Labem
Luděk Vašátko, MUDr. principal investigator
Masaryk Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical block in people with Cervical Plexus Block Comparison, run by Daniel Nalos MD at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of additional applications of short-acting local anaesthetic (time frame: intraoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608126, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2012.