AnesthesiaNCT05353218
Ultrasound-Guided Intermediate Versus Deep Cervical Plexus Block for Carotid Endarterectomy
A study testing Intermediate cervical plexus block and Deep cervical plexus block in people with Anesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Cervical plexus blocks are regional methods used in carotid endarterectomy. Cervical plexus blocks consist of three blocks: superficial, intermediate and deep. These three blocks can be used alone or combined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Intermediate cervical plexus block and Deep cervical plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jun 2022to 27 Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for carotid endarterectom y surgery.
Who cannot join
- Local infection
- Previous ipsilateral surgery
- Radiotherapy
- Conversion to general anesthesia
- Known bleeding disorders
- Known allergy of local anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ultrasound-Guided Intermediate Versus Deep Cervical Plexus Block for Carotid Endarterectomy: A Randomized Controlled Trial
Cervical plexus blocks are regional methods used in carotid endarterectomy. Cervical plexus blocks consist of three blocks: superficial, intermediate and deep. These three blocks can be used alone or combined. The aim of this study is to evaluate the effectiveness of ultrasound-guided intermediate and deed cervical plexus block in patients undergoing carotid endarterectomy.
Read the detailed description
Carotid endarterectomy is a surgical method used to treat occlusive lesions of the carotid. Regional anesthesia is preferred because it allows for consciousness control and neurological examination during the operation. Cervical plexus blocks are regional methods used in carotid endarterectomy. It is a regional technique in which the cervical spinal nerves (C2-C3-C4) are blocked with a local anesthetic agent from different regions. Cervical plexus blocks consist of three blocks: superficial, intermediate and deep, depending on the depth at which the local anesthetic agent is infiltrated. According to the preference of the clinician for the purpose of anesthesia, these three blocks can be used separately or combined. It is mentioned that all three blocks provide sufficient anesthesia for carotid endarterectomy surgery to be performed.
In the study, investigators planned to evaluate the effectiveness of ultrasound-guided intermediate and deep cervical plexus blocks in patients undergoing carotid endarterectomy by comparing the number of patients who need additional local anesthetics.
- Conditions
- Anesthesia
- Being tested
- Intermediate cervical plexus block, Deep cervical plexus block
- Keywords
- cervical plexus block, Endarterectomy, Carotid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermediate cervical plexus blockProcedure or surgery
Intermediate cervical plexus block will be applied in transverse plane using posterior approach at C4.
Deep cervical plexus blockProcedure or surgery
Deep cervical plexus block will be appliedin transverse plane using anterior approach at C2-3-4.
| Study group | Role | What they receive |
|---|---|---|
| Group intermediate cervical plexus block (GI) | Active comparator | Patients anesthetized with intermediate cervical plexus block. Receives: Procedure: Intermediate cervical plexus block |
| Group deep cervical plexus block (GD) | Active comparator | Patients anesthetized with deep cervical plexus block. Receives: Procedure: Deep cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient needed supplemental local anesthetic
If patients complain about pain above visual analog scale 3, 4ml 1% lidocaine is injected by surgeon.
Measured: Intraoperative 2-3 hours
Secondary outcomes (8)
Amount of supplemental local anesthetic
If patients complain about pain above visual analog scale 3, 4ml 1% lidocaine is injected by surgeon.
Measured: Intraoperative 2-3 hours
Duration of blocks' application
time from the insertion of probe to the removal of needle from skin
Measured: Up to 15 minutes
Region where patient needs supplemental local anesthetic
Region where supplemental lidocaine is injected by surgeon
Measured: Intraoperative 2-3 hours
Amount of remifentanil
Amount of remifentanil (0.02mcg/kg/min) infused during surgery for sedation.
Measured: Intraoperative 2-3 hours
Pain assessment
Pain assessment will be assessed using visual analog scale (VAS 0 to 10; 0: no pain, 10: the worst pain imaginable )
Measured: Intraoperative 2-3 hours
Complications
Hematoma, dysphagia, hoarseness, facial paralysis, Horner's syndrome, intravascular or intrathecal injection
Measured: Up to 24 hours
Patient's satisfaction
Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)
Measured: Up to 24 hours
Surgeon's satisfaction
Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start7 Jun 2022
- Primary completion15 Jan 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Prospective
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Turhan, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353218
- Sponsor's protocol ID
- 2021/923
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turhan O, Sivrikoz N, Canbolat N, Demirel EE, Altun D, Sungur Z. Ultrasound-guided intermediate versus deep cervical plexus block for carotid endarterectomy: a randomized controlled study. BMC Anesthesiol. 2025 Nov 21;25(1):581. doi: 10.1186/s12871-025-03460-w.
PubMed 41272478
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-Guided Intermediate Versus Deep Cervical Plexus Block for Carotid Endarterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05353218
- Acronym / sponsor ID
- 2021/923
- Conditions
- Anesthesia
- Keywords
- cervical plexus block, Endarterectomy, Carotid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- 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.
Cervical plexus blocks are regional methods used in carotid endarterectomy. Cervical plexus blocks consist of three blocks: superficial, intermediate and deep. These three blocks can be used alone or combined. The aim of this study is to evaluate the effectiveness of ultrasound-guided intermediate and deed cervical plexus block in patients undergoing carotid endarterectomy.
Detailed description
Carotid endarterectomy is a surgical method used to treat occlusive lesions of the carotid. Regional anesthesia is preferred because it allows for consciousness control and neurological examination during the operation. Cervical plexus blocks are regional methods used in carotid endarterectomy. It is a regional technique in which the cervical spinal nerves (C2-C3-C4) are blocked with a local anesthetic agent from different regions. Cervical plexus blocks consist of three blocks: superficial, intermediate and deep, depending on the depth at which the local anesthetic agent is infiltrated. According to the preference of the clinician for the purpose of anesthesia, these three blocks can be used separately or combined. It is mentioned that all three blocks provide sufficient anesthesia for carotid endarterectomy surgery to be performed.
In the study, investigators planned to evaluate the effectiveness of ultrasound-guided intermediate and deep cervical plexus blocks in patients undergoing carotid endarterectomy by comparing the number of patients who need additional local anesthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Prospective
| Arm | Type | Receives |
|---|---|---|
| Group intermediate cervical plexus block (GI) | Active comparator | Procedure: Intermediate cervical plexus blockPatients anesthetized with intermediate cervical plexus block. |
| Group deep cervical plexus block (GD) | Active comparator | Procedure: Deep cervical plexus blockPatients anesthetized with deep cervical plexus block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for carotid endarterectom y surgery.
Key exclusion criteria (6 listed)
- Local infection
- Previous ipsilateral surgery
- Radiotherapy
- Conversion to general anesthesia
- Known bleeding disorders
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 |
|---|---|---|
| Intermediate cervical plexus blockIntermediate cervical plexus block will be applied in transverse plane using posterior approach at C4. | Procedure or surgery | Group intermediate cervical plexus block (GI) |
| Deep cervical plexus blockDeep cervical plexus block will be appliedin transverse plane using anterior approach at C2-3-4. | Procedure or surgery | Group deep cervical plexus block (GD) |
Primary outcome
Number of patient needed supplemental local anesthetic
Time frame: Intraoperative 2-3 hours
If patients complain about pain above visual analog scale 3, 4ml 1% lidocaine is injected by surgeon.
8 secondary outcomes
Amount of supplemental local anesthetic
Time frame: Intraoperative 2-3 hours
Duration of blocks' application
Time frame: Up to 15 minutes
Region where patient needs supplemental local anesthetic
Time frame: Intraoperative 2-3 hours
Amount of remifentanil
Time frame: Intraoperative 2-3 hours
Pain assessment
Time frame: Intraoperative 2-3 hours
Complications
Time frame: Up to 24 hours
Patient's satisfaction
Time frame: Up to 24 hours
Surgeon's satisfaction
Time frame: Up to 24 hours
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 28 Apr 2023.
- Derived from this study: PubMed 41272478Turhan O, Sivrikoz N, Canbolat N, Demirel EE, Altun D, Sungur Z. Ultrasound-guided intermediate versus deep cervical plexus block for carotid endarterectomy: a randomized controlled study. BMC Anesthesiol. 2025 Nov 21;25(1):581. doi: 10.1186/s12871-025-03460-w.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermediate cervical plexus block and Deep cervical plexus block in people with Anesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
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 6 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 28 Apr 2023. 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 Turkey (Türkiye). 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 patient needed supplemental local anesthetic (time frame: Intraoperative 2-3 hours). 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 NCT05353218, which also lists 1 linked publication.
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 28 Apr 2023.