Patient SatisfactionNCT05362162
Comparison of Intermediate Cervical Plexus Block and Superficial Cervical Plexus Block
A study testing cervical plexus block in people with Patient Satisfaction, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- cervical plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2022to 5 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- cervical plexus block
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical plexus blockProcedure or surgery
local anesthetic agent injection into the either Superficial or intermediate area
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction and procedural comfort
Likert scale; Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied
Measured: 30 minutes following block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start25 May 2022
- Primary completion5 Nov 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362162
- Sponsor's protocol ID
- Central Venous Catheterization
- Status last verified
- May 2022
- First submitted
- 1 May 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intermediate Cervical Plexus Block and Superficial Cervical Plexus Block for Central Venous Catheterization; Prospective and Randomized Study
- ClinicalTrials.gov ID
- NCT05362162
- Acronym / sponsor ID
- Central Venous Catheterization
- Conditions
- Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Active comparator | Procedure: cervical plexus blockSuperficial 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 I | Active comparator | Procedure: cervical plexus blockIntermediate 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical plexus blocklocal anesthetic agent injection into the either Superficial or intermediate area | Procedure or surgery | Group I, Group S |
Primary outcome
patient satisfaction and procedural comfort
Time frame: 30 minutes following block
Likert scale; Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical plexus block in people with Patient Satisfaction, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction and procedural comfort (time frame: 30 minutes following block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.