Catheterization, Central VenousNCT07841782
Comparison of Local Infiltration Anesthesia and Superficial Cervical Plexus Block in Ultrasound-Guided Internal Jugular Vein Catheterization: Efficacy, Duration, and Local Anesthetic Volume
A study testing Lidocaine HCl 1% in people with Catheterization, Central Venous and Pain, Procedural, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Internal jugular vein (IJV) catheterization is a common invasive procedure performed under ultrasound (USG) guidance. Providing effective analgesia during the procedure is essential for patient comfort. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Catheterization, Central Venous, Pain, Procedural, Internal Jugular Vein Cannulation
- What is being tested?
- Lidocaine HCl 1%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Jul 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 80 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Glasgow Coma Scale (GCS) score between 13 and 15
- Patients scheduled for elective or semi-elective ultrasound-guided internal jugular vein catheterization
- Patients who are literate, capable of effective communication, and provide written informed consent
Who cannot join
- Glasgow Coma Scale (GCS) score < 13
- Age < 18 years or > 80 years
- ASA physical status IV or higher
- Internal jugular vein catheterization performed under general anesthesia
- Internal jugular vein catheterization performed under emergency conditions
- Distorted head and neck anatomy preventing adequate ultrasound visualization for the block
Show all 9Show fewer
- Arterial puncture on the first needle insertion attempt
- Illiterate patients or patients unable to establish effective communication to evaluate pain scores
- Known allergy or hypersensitivity to local anesthetics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
kayseri City Hospital Department of Anesthesiology and Reanimation
Kayseri, 38080
About this study
Official title: Comparison of Local Infiltration Anesthesia and Superficial Cervical Plexus Block in Ultrasound-Guided Internal Jugular Vein Catheterization: Efficacy, Duration, and Local Anesthetic Volume - A Randomized Controlled Trial
Internal jugular vein (IJV) catheterization is a common invasive procedure performed under ultrasound (USG) guidance. Providing effective analgesia during the procedure is essential for patient comfort. This prospective, randomized controlled study aims to compare the clinical efficacy, onset time, required local anesthetic volume, and hemodynamic stability between ultrasound-guided local infiltration anesthesia (LIA) and ultrasound-guided superficial cervical plexus block (SCPB) using different volumes (2 mL, 5 mL, and 10 mL of 1% lidocaine) in patients undergoing IJV catheterization.
Read the detailed description
Central venous catheterization (CVC) is a widely used invasive procedure in critically ill and high-risk surgical patients for fluid resuscitation, hemodynamic monitoring, continuous infusion of vasoactive or venosclerotic drugs, and hemodialysis/hemofiltration. Among available vascular access sites, internal jugular vein (IJV) cannulation is the most commonly preferred route. However, awake patients undergoing IJV catheterization often experience significant pain and distress, which may negatively impact hemodynamic stability, patient comfort, and procedural success.
Although local infiltration anesthesia (LIA) is traditionally used to provide analgesia during IJV catheterization, it frequently falls short of providing optimal pain control. Ultrasound-guided regional anesthesia techniques, such as superficial cervical plexus block (SCPB), have emerged as effective alternatives for procedures involving the anterolateral neck region.
While both LIA and SCPB are utilized in clinical practice, there is a lack of prospective randomized literature directly comparing different local anesthetic volumes, onset times, and overall clinical efficacy between these two approaches. This prospective, randomized controlled trial aims to evaluate and compare ultrasound-guided LIA and SCPB in terms of anesthetic efficacy, onset time, required local anesthetic volume, and hemodynamic stability in patients undergoing IJV catheterization.
- Being tested
- Lidocaine HCl 1%
- Keywords
- internal jugular venous catheterization, local infiltration anesthesia, superficial cervical plexus block, central venous catheterization
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HCl 1%Drug
Also called LİDON %2 (diluted %1)
Administration of 1% lidocaine hydrochloride either via ultrasound-guided superficial cervical plexus block (at 2 mL, 5 mL, or 10 mL volumes) or via subcutaneous local infiltration (10 mL) prior to internal jugular vein catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Local Infiltration Anesthesia (LIA Group) | Active comparator | 10 mL of 1% lidocaine hydrochloride is injected subcutaneously over the sternocleidomastoid muscle at the C6 level for local infiltration prior to internal jugular vein catheterization (n=75). Receives: Drug: Lidocaine HCl 1% |
| Superficial Cervical Plexus Block - 2 mL (SCPB 2 mL) | Experimental | Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 2 mL of 1% lidocaine hydrochloride (n=25). Receives: Drug: Lidocaine HCl 1% |
| Superficial Cervical Plexus Block - 5 mL (SCPB 5 mL) | Experimental | Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 5 mL of 1% lidocaine hydrochloride (n=25). Receives: Drug: Lidocaine HCl 1% |
| Superficial Cervical Plexus Block - 10 mL (SCPB 10 mL) | Experimental | Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 10 mL of 1% lidocaine hydrochloride (n=25). Receives: Drug: Lidocaine HCl 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Effective Block Onset Across Different Local Anesthetic Volumes
Time elapsed (in seconds) from injection completion until effective analgesia is achieved (defined as an NRS score ≤ 2 via pin-prick test every 5 seconds), evaluating whether lower volumes of SCPB (2 mL and 5 mL) achieve effective block onset in a comparable timeframe to higher volume SCPB (10 mL) and standard LIA (10 mL).
Measured: Evaluated every 5 seconds, up to 5 minutes post-injection.
Time to Effective Block Onset Across Different Local Anesthetic Volumes
Time elapsed (in seconds) from injection completion until effective analgesia is achieved (defined as an NRS score ≤ 2 via pin-prick test every 5 seconds), evaluating whether lower volumes of SCPB (2 mL and 5 mL) achieve effective block onset in a comparable timeframe to higher volume SCPB (10 mL) and standard LIA (10 mL).
Measured: Evaluated every 5 seconds, up to 5 minutes post-injection
Secondary outcomes (1)
Pain Intensity Across Procedural Stages (NRS Scores)
Evaluation of pain intensity using the Numerical Rating Scale (NRS, 0 = no pain to 10 = worst pain) to compare whether low-volume SCPB provides comparable pain control to high-volume SCPB and LIA across different procedural steps.
Measured: At baseline, during infiltration/block injection, during initial needle insertion, and during catheter placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Jun 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheterization, Central VenousStudies 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
- Model description
- A prospective, randomized, parallel-group clinical trial with four study arms. Eligible patients undergoing ultrasound-guided internal jugular vein catheterization are randomly allocated using a sealed-envelope method into either the Local Infiltration Anesthesia group (LIA, n=75) or one of the three Superficial Cervical Plexus Block volume subgroups (SCPB 2 mL, SCPB 5 mL, or SCPB 10 mL; n=25 per subgroup).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, AYŞENUR SELEK, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841782
- Sponsor's protocol ID
- 2025/81
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality and due to lack of a dedicated data repository protocol.
Publications
Tkle HA, Pat l BM. Comparison of superfical cervical plexus block versus local infiltration for pain relief during internal jugular ven cannulation. Int J Contemp Med Res. 2018;5:I6-12.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Local Infiltration Anesthesia and Superficial Cervical Plexus Block in Ultrasound-Guided Internal Jugular Vein Catheterization: Efficacy, Duration, and Local Anesthetic Volume - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07841782
- Acronym / sponsor ID
- 2025/81
- Keywords
- internal jugular venous catheterization, local infiltration anesthesia, superficial cervical plexus block, central venous catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 25 Sep 2026 (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.
Internal jugular vein (IJV) catheterization is a common invasive procedure performed under ultrasound (USG) guidance. Providing effective analgesia during the procedure is essential for patient comfort. This prospective, randomized controlled study aims to compare the clinical efficacy, onset time, required local anesthetic volume, and hemodynamic stability between ultrasound-guided local infiltration anesthesia (LIA) and ultrasound-guided superficial cervical plexus block (SCPB) using different volumes (2 mL, 5 mL, and 10 mL of 1% lidocaine) in patients undergoing IJV catheterization.
Detailed description
Central venous catheterization (CVC) is a widely used invasive procedure in critically ill and high-risk surgical patients for fluid resuscitation, hemodynamic monitoring, continuous infusion of vasoactive or venosclerotic drugs, and hemodialysis/hemofiltration. Among available vascular access sites, internal jugular vein (IJV) cannulation is the most commonly preferred route. However, awake patients undergoing IJV catheterization often experience significant pain and distress, which may negatively impact hemodynamic stability, patient comfort, and procedural success.
Although local infiltration anesthesia (LIA) is traditionally used to provide analgesia during IJV catheterization, it frequently falls short of providing optimal pain control. Ultrasound-guided regional anesthesia techniques, such as superficial cervical plexus block (SCPB), have emerged as effective alternatives for procedures involving the anterolateral neck region.
While both LIA and SCPB are utilized in clinical practice, there is a lack of prospective randomized literature directly comparing different local anesthetic volumes, onset times, and overall clinical efficacy between these two approaches. This prospective, randomized controlled trial aims to evaluate and compare ultrasound-guided LIA and SCPB in terms of anesthetic efficacy, onset time, required local anesthetic volume, and hemodynamic stability in patients undergoing IJV catheterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- A prospective, randomized, parallel-group clinical trial with four study arms. Eligible patients undergoing ultrasound-guided internal jugular vein catheterization are randomly allocated using a sealed-envelope method into either the Local Infiltration Anesthesia group (LIA, n=75) or one of the three Superficial Cervical Plexus Block volume subgroups (SCPB 2 mL, SCPB 5 mL, or SCPB 10 mL; n=25 per subgroup).
| Arm | Type | Receives |
|---|---|---|
| Local Infiltration Anesthesia (LIA Group) | Active comparator | Drug: Lidocaine HCl 1%10 mL of 1% lidocaine hydrochloride is injected subcutaneously over the sternocleidomastoid muscle at the C6 level for local infiltration prior to internal jugular vein catheterization (n=75). |
| Superficial Cervical Plexus Block - 2 mL (SCPB 2 mL) | Experimental | Drug: Lidocaine HCl 1%Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 2 mL of 1% lidocaine hydrochloride (n=25). |
| Superficial Cervical Plexus Block - 5 mL (SCPB 5 mL) | Experimental | Drug: Lidocaine HCl 1%Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 5 mL of 1% lidocaine hydrochloride (n=25). |
| Superficial Cervical Plexus Block - 10 mL (SCPB 10 mL) | Experimental | Drug: Lidocaine HCl 1%Ultrasound-guided superficial cervical plexus block administered beneath the sternocleidomastoid muscle at the C6 level using 10 mL of 1% lidocaine hydrochloride (n=25). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 18 and 80 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Glasgow Coma Scale (GCS) score between 13 and 15
- Patients scheduled for elective or semi-elective ultrasound-guided internal jugular vein catheterization
- Patients who are literate, capable of effective communication, and provide written informed consent
Key exclusion criteria (9 listed)
- Glasgow Coma Scale (GCS) score < 13
- Age < 18 years or > 80 years
- ASA physical status IV or higher
- Internal jugular vein catheterization performed under general anesthesia
- Internal jugular vein catheterization performed under emergency conditions
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 |
|---|---|---|
| Lidocaine HCl 1%Also: LİDON %2 (diluted %1)Administration of 1% lidocaine hydrochloride either via ultrasound-guided superficial cervical plexus block (at 2 mL, 5 mL, or 10 mL volumes) or via subcutaneous local infiltration (10 mL) prior to internal jugular vein catheterization. | Drug | Local Infiltration Anesthesia (LIA Group), Superficial Cervical Plexus Block - 10 mL (SCPB 10 mL), Superficial Cervical Plexus Block - 2 mL (SCPB 2 mL), Superficial Cervical Plexus Block - 5 mL (SCPB 5 mL) |
Primary outcome
Time to Effective Block Onset Across Different Local Anesthetic Volumes
Time frame: Evaluated every 5 seconds, up to 5 minutes post-injection.
Time elapsed (in seconds) from injection completion until effective analgesia is achieved (defined as an NRS score ≤ 2 via pin-prick test every 5 seconds), evaluating whether lower volumes of SCPB (2 mL and 5 mL) achieve effective block onset in a comparable timeframe to higher volume SCPB (10 mL) and standard LIA (10 mL).
Time to Effective Block Onset Across Different Local Anesthetic Volumes
Time frame: Evaluated every 5 seconds, up to 5 minutes post-injection
Time elapsed (in seconds) from injection completion until effective analgesia is achieved (defined as an NRS score ≤ 2 via pin-prick test every 5 seconds), evaluating whether lower volumes of SCPB (2 mL and 5 mL) achieve effective block onset in a comparable timeframe to higher volume SCPB (10 mL) and standard LIA (10 mL).
1 secondary outcome
Pain Intensity Across Procedural Stages (NRS Scores)
Time frame: At baseline, during infiltration/block injection, during initial needle insertion, and during catheter placement.
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 7 Oct 2026.
- Results publicationTkle HA, Pat l BM. Comparison of superfical cervical plexus block versus local infiltration for pain relief during internal jugular ven cannulation. Int J Contemp Med Res. 2018;5:I6-12.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality and due to lack of a dedicated data repository protocol.
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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 Lidocaine HCl 1% in people with Catheterization, Central Venous and Pain, Procedural, run by Kayseri City 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 5 inclusion and 9 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 7 Oct 2026. 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?
Time to Effective Block Onset Across Different Local Anesthetic Volumes (time frame: Evaluated every 5 seconds, up to 5 minutes post-injection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07841782, which also lists 1 linked publication.
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 7 Oct 2026.