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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Intermediate cervical plexus block; Procedure: Deep cervical plexus block

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Özlem Turhan; Phone Number: +905055381923; Email: ozlemturhan6@gmail.com
• Study Contact Backup: Name: Nükhet Sivrikoz; Phone Number: 31742 +902124142000; Email: ntsz06@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group intermediate cervical plexus block (GI); Patients anesthetized with intermediate cervical plexus block.	Procedure: Intermediate cervical plexus block; Intermediate cervical plexus block will be applied in transverse plane using posterior approach at C4.
Active Comparator: Group deep cervical plexus block (GD); Patients anesthetized with deep cervical plexus block.	Procedure: Deep cervical plexus block; Deep cervical plexus block will be appliedin transverse plane using anterior approach at C2-3-4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Duration of blocks' application	time from the insertion of probe to the removal of needle from skin	Up to 15 minutes
Region where patient needs supplemental local anesthetic	Region where supplemental lidocaine is injected by surgeon	Intraoperative 2-3 hours
Amount of remifentanil	Amount of remifentanil (0.02mcg/kg/min) infused during surgery for sedation.	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 )	Intraoperative 2-3 hours
Complications	Hematoma, dysphagia, hoarseness, facial paralysis, Horner's syndrome, intravascular or intrathecal injection	Up to 24 hours
Patient's satisfaction	Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)	Up to 24 hours
Surgeon's satisfaction	Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)	Up to 24 hours

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Endarterectomy, Carotid; cervical plexus block
• Other Study ID Numbers: 2021/923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No