Ultrasound-Guided Intermediate Versus Deep Cervical Plexus Block for Carotid Endarterectomy

Anesthesia Clinical Trial

Official title:

Efficacy of Ultrasound-Guided Intermediate Versus Deep Cervical Plexus Block for Carotid Endarterectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05353218
• Other study ID #: 2021/923
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia

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