Comparison of Intermediate Cervical Plexus Block and Superficial Cervical Plexus Block

Comparison of Intermediate Cervical Plexus Block and Superficial Cervical Plexus Block for Central Venous Catheterization; Prospective and Randomized Study

Central venous catheterization is a common procedure in hospitals. Internal jugular vein (IJV) cannulation is the most preferred vein for this purpose. During the procedure, infiltration of local anesthetic (LA) agents into the skin and subcutaneous tissues is a commonly used method to provide patient comfort and reduce pain. There is an increasing need to improve the quality of health care delivery. An important component of health service quality is patient satisfaction. The aim of this study is to compare the superficial cervical plexus block and the intermediate cervical plexus block applied under the guidance of ultrasound in terms of patient satisfaction and procedural comfort during central catheterization of the internal jugular vein.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Procedure: cervical plexus block

Detailed Description

This prospective randomized study will be performed on patients undergoing central venous catheterization into the internal jugular vein. Patients who agreed to participate in the study will be divided into two groups using the closed-envelope randomization method; Group S: Superficial cervical plexus block group Group I: Intermediate cervical plexus group

After routine monitoring and RAMSEY 2 level sedation is achieved, a superficial or intermediate cervical plexus block will be applied according to randomization by a researcher experienced in a peripheral block. Patient pain level (to be evaluated with the Numeric Pain Rating Scale) during the block and catheterization procedure (first needle insertion, dilatation, catheter placement, and suture phase). Thirty minutes after the procedure, patient satisfaction will be evaluated with a Likert-type scale.

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

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42005
    • Betul Kozanhan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult volunteer patients who require central catheterization into the internal jugular vein for any reason
• Patients with mental and health status who can understand the research questions.
• Patients who read the informed consent form and gave a signed declaration of acceptance

Exclusion Criteria:

• Patients with psychiatric disorders
• Patients who are in poor general condition and require urgent intervention
• Patients who cannot answer the survey questions
• Patients followed as intubated
• Patients with hypersensitivity to the local anesthetic agents to be used in the study or to the substances contained in it.
• Patients with contraindications for cervical plexus block application
• Patients who are unwilling to participate in the study for any reason

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 S; Superficial cervical plexus block; After asepsis and antisepsis are achieved, it will be performed by injecting 10 ml of the local anesthetic agent into the subcutaneous area in the anterolateral neck region, from the anatomical region that fits the carotid artery bifurcation point, under the guidance of USG.	Procedure: cervical plexus block; local anesthetic agent injection into the either Superficial or intermediate area
Active Comparator: Group I; Intermediate cervical plexus block; After asepsis and antisepsis are achieved, it will be performed by injecting 10 ml of the local anesthetic agent under the investing fascia from the anatomical region that fits the carotid artery bifurcation point under the guidance of USG.	Procedure: cervical plexus block; local anesthetic agent injection into the either Superficial or intermediate area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction and procedural comfort	Likert scale; Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied	30 minutes following block

Collaborators and Investigators

• Sponsor: Konya Meram State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): November 5, 2022
• Study Completion (Actual): November 5, 2022

Study Registration Dates

• First Submitted: May 1, 2022
• First Submitted That Met QC Criteria: May 1, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Central Venous Catheterization

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