Comparison of Intermediate Cervical Plexus Block and Superficial Cervical Plexus Block

NCT ID: NCT05362162

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2022-11-05

Brief Summary

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.

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.

Conditions

Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

cervical plexus block

Intervention Type: PROCEDURE

local anesthetic agent injection into the either Superficial or intermediate area

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.

Group Type: ACTIVE_COMPARATOR

cervical plexus block

Intervention Type: PROCEDURE

local anesthetic agent injection into the either Superficial or intermediate area

Interventions

cervical plexus block

local anesthetic agent injection into the either Superficial or intermediate area

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya Meram State Hospital

OTHER

Sponsor Role: lead

Responsible Party

Betul Kozanhan

Ass.Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Betul Kozanhan

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Central Venous Catheterization

Identifier Type: -

Identifier Source: org_study_id