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Completed

NCT Number: NCT05353218

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intermediate cervical plexus block

Procedure

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

Deep cervical plexus block

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Amount of 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.

  2. Duration of blocks' application

    Time frame: Up to 15 minutes

    time from the insertion of probe to the removal of needle from skin

  3. Region where patient needs supplemental local anesthetic

    Time frame: Intraoperative 2-3 hours

    Region where supplemental lidocaine is injected by surgeon

  4. Amount of remifentanil

    Time frame: Intraoperative 2-3 hours

    Amount of remifentanil (0.02mcg/kg/min) infused during surgery for sedation.

  5. Pain assessment

    Time frame: Intraoperative 2-3 hours

    Pain assessment will be assessed using visual analog scale (VAS 0 to 10; 0: no pain, 10: the worst pain imaginable )

  6. Complications

    Time frame: Up to 24 hours

    Hematoma, dysphagia, hoarseness, facial paralysis, Horner's syndrome, intravascular or intrathecal injection

  7. Patient's satisfaction

    Time frame: Up to 24 hours

    Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)

  8. Surgeon's satisfaction

    Time frame: Up to 24 hours

    Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2022
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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