NCT05353218

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 7, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 24, 2022

Last Update Submit

April 27, 2023

Conditions

Keywords

cervical plexus blockEndarterectomy, Carotid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Amount of supplemental local anesthetic

    Intraoperative 2-3 hours

  • Duration of blocks' application

    Up to 15 minutes

  • Region where patient needs supplemental local anesthetic

    Intraoperative 2-3 hours

  • Amount of remifentanil

    Intraoperative 2-3 hours

  • Pain assessment

    Intraoperative 2-3 hours

  • +3 more secondary outcomes

Study Arms (2)

Group intermediate cervical plexus block (GI)

ACTIVE COMPARATOR

Patients anesthetized with intermediate cervical plexus block.

Procedure: Intermediate cervical plexus block

Group deep cervical plexus block (GD)

ACTIVE COMPARATOR

Patients anesthetized with deep cervical plexus block.

Procedure: Deep cervical plexus block

Interventions

Intermediate cervical plexus block will be applied in transverse plane using posterior approach at C4.

Group intermediate cervical plexus block (GI)

Deep cervical plexus block will be appliedin transverse plane using anterior approach at C2-3-4.

Group deep cervical plexus block (GD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for carotid endarterectom y surgery.

You may not qualify if:

  • Local infection
  • Previous ipsilateral surgery
  • Radiotherapy
  • Conversion to general anesthesia
  • Known bleeding disorders
  • Known allergy of local anesthetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, Prospective
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

April 24, 2022

First Posted

April 29, 2022

Study Start

June 7, 2022

Primary Completion

January 15, 2023

Study Completion

April 27, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations