NCT05362162

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.

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 May 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2022

Completed
Last Updated

November 8, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

May 1, 2022

Last Update Submit

November 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction and procedural comfort

    Likert scale; Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied

    30 minutes following block

Study Arms (2)

Group S

ACTIVE COMPARATOR

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

Group I

ACTIVE COMPARATOR

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

Interventions

local anesthetic agent injection into the either Superficial or intermediate area

Group IGroup S

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Cervical Plexus Block

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

May 1, 2022

First Posted

May 5, 2022

Study Start

May 25, 2022

Primary Completion

November 5, 2022

Study Completion

November 5, 2022

Last Updated

November 8, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations