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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05353218
Other study ID # 2021/923
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2022
Est. completion date April 27, 2023

Study information

Verified date April 2023
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The aim of this study is to evaluate the effectiveness of ultrasound-guided intermediate and deed cervical plexus block in patients undergoing carotid endarterectomy.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 27, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients scheduled for carotid endarterectom y surgery. Exclusion Criteria: - Local infection - Previous ipsilateral surgery - Radiotherapy - Conversion to general anesthesia - Known bleeding disorders - Known allergy of local anesthetic

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intermediate cervical plexus block
Intermediate cervical plexus block will be applied in transverse plane using posterior approach at C4.
Deep cervical plexus block
Deep cervical plexus block will be appliedin transverse plane using anterior approach at C2-3-4.

Locations

Country Name City State
Turkey Istanbul Faculty of Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patient needed supplemental local anesthetic If patients complain about pain above visual analog scale 3, 4ml 1% lidocaine is injected by surgeon. Intraoperative 2-3 hours
Secondary Amount of supplemental local anesthetic If patients complain about pain above visual analog scale 3, 4ml 1% lidocaine is injected by surgeon. Intraoperative 2-3 hours
Secondary Duration of blocks' application time from the insertion of probe to the removal of needle from skin Up to 15 minutes
Secondary Region where patient needs supplemental local anesthetic Region where supplemental lidocaine is injected by surgeon Intraoperative 2-3 hours
Secondary Amount of remifentanil Amount of remifentanil (0.02mcg/kg/min) infused during surgery for sedation. Intraoperative 2-3 hours
Secondary Pain assessment Pain assessment will be assessed using visual analog scale (VAS 0 to 10; 0: no pain, 10: the worst pain imaginable ) Intraoperative 2-3 hours
Secondary Complications Hematoma, dysphagia, hoarseness, facial paralysis, Horner's syndrome, intravascular or intrathecal injection Up to 24 hours
Secondary Patient's satisfaction Likert scale:1-5 (1: very dissatisfied, 5: very satisfied) Up to 24 hours
Secondary Surgeon's satisfaction Likert scale:1-5 (1: very dissatisfied, 5: very satisfied) Up to 24 hours
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