Infraclavicular Brachial Plexus BlockNCT07669688
Pulse Wave Transit Time After Infraclavicular Block
An observational study of Infraclavicular Brachial Plexus Block, run by Sakarya University at 2 sites in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the time-dependent changes in Pulse Wave Transit Time (PWTT) following ultrasound-guided infraclavicular brachial plexus block. PWTT is a non-invasive hemodynamic parameter reflecting vascular tone and sympathetic nervous system activity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infraclavicular Brachial Plexus Block
- What is being tested?
- Ultrasound-guided infraclavicular brachial plexus block
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 26 Oct 2026to 15 Nov 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult patients aged 18-65 years with ASA physical status I who are scheduled to undergo elective upper extremity hand surgery under ultrasound-guided infraclavicular brachial plexus block. All participants will receive standard-of-care anesthesia management. Patients with contraindications to peripheral nerve block, significant systemic disease, obesity (BMI ≥30 kg/m²), coagulation disorders, opioid use, or conditions affecting sympathetic activity will be excluded. Only patients who provide informed consent will be enrolled.
Who may be able to join
- Patients undergoing elective upper extremity hand surgery
- 18 - 65 years
- ASA I
- No coagulopathy, thrombocytopenia, coagulation disorders
- Patients who provide informed consent to participate in the study
Who cannot join
- History of drug allergy relevant to study procedures or local anesthetics
- Body mass index (BMI) ≥ 30 kg/m²
- Body weight < 40 kg
- Age < 18 years or > 65 years
- History of significant cardiac disease (e.g., arrhythmia, conduction abnormalities)
- Coagulopathy (INR > 1.5 or platelet count < 100,000/mm³)
Show all 12Show fewer
- Pregnancy or lactation
- Infection at the site of peripheral nerve block
- ASA II-IV
- Failed block or motor block duration exceeding 30 minutes
- Patients reporting pain (NRS ≥ 3), due to potential influence on sympathetic activity
- Chronic opioid use
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Sakarya University-Anesthesiology and Reanimation Department
Sakarya
Burçin Alaçam, +905465903851, burcin.ersoy90@gmail.com
- Recruiting
Sakarya University-Anesthesiology and Reanimation Department
Sakarya
About this study
Official title: Time-Dependent Changes in Pulse Wave Transit Time Following Infraclavicular Block: A Non-Invasive Assessment of Sympathetic Blockade
This prospective observational study aims to evaluate the time-dependent changes in Pulse Wave Transit Time (PWTT) following ultrasound-guided infraclavicular brachial plexus block. PWTT is a non-invasive hemodynamic parameter reflecting vascular tone and sympathetic nervous system activity. Patients undergoing upper extremity surgery under infraclavicular block will be monitored using standard perioperative monitoring devices. PWTT measurements will be obtained before and after block placement at predefined time intervals. Secondary outcomes will include perfusion index, skin temperature, heart rate, blood pressure, respiratory rate, and oxygen saturation. The study seeks to determine whether PWTT can serve as an objective and non-invasive marker of sympathetic blockade following infraclavicular block.
Read the detailed description
Regional anesthesia success is traditionally assessed using sensory and motor block evaluation methods that rely on patient cooperation and subjective responses to external stimuli. However, these methods may be difficult to apply in sedated, uncooperative, or communication-impaired patients. Therefore, objective and non-invasive indicators of sympathetic blockade have gained increasing interest in regional anesthesia practice.
Pulse Wave Transit Time (PWTT) is defined as the time interval between the R-wave on the electrocardiogram and the arrival of the corresponding pulse wave detected by a peripheral pulse oximeter. PWTT reflects vascular tone, arterial compliance, and hemodynamic status. Sympathetic blockade induced by peripheral nerve blocks results in vasodilation and reduced vascular resistance, potentially leading to measurable changes in PWTT. Previous studies have demonstrated the utility of objective parameters such as perfusion index, skin temperature, blood flow measurements, and PWTT in assessing block success. However, data regarding the temporal changes of PWTT following infraclavicular brachial plexus block remain limited.
The primary objective of this prospective observational study is to investigate the time-dependent changes in PWTT after ultrasound-guided infraclavicular brachial plexus block. The study will be conducted in patients undergoing upper extremity surgery under infraclavicular block at Sakarya Training and Research Hospital.
Patients scheduled to receive infraclavicular block as part of their routine clinical care will be enrolled after providing informed consent. The block procedure is not performed for research purposes and represents standard clinical practice. Following block administration, PWTT values will be recorded from the blocked extremity using standard monitoring equipment. Measurements will be obtained before block placement and at 0, 5, 10, 15, and 20 minutes after block completion. Baseline PWTT measurements will also be obtained from the contralateral upper extremity.
Secondary outcome measures will include perfusion index, skin temperature of both upper extremities, heart rate, non-invasive blood pressure, respiratory rate, and oxygen saturation. Demographic and clinical data will also be recorded.
All measurements will be collected according to a predefined protocol using standardized monitoring equipment. Since PWTT is an objective device-derived parameter, observer dependency is expected to be minimal. Data collection personnel will be separated from the clinician performing the block whenever feasible to reduce measurement bias. All collected data will be anonymized prior to statistical analysis.
This study is designed as a single-center, prospective observational investigation without randomization or intervention beyond routine clinical care. The findings may contribute to the development of PWTT as a practical, objective, and non-invasive marker of sympathetic blockade following infraclavicular brachial plexus block.
- Conditions
- Infraclavicular Brachial Plexus Block
- Being tested
- Ultrasound-guided infraclavicular brachial plexus block
- Keywords
- Infraclavicular Block, Pulse Wave Transit Time, Regional Anesthesia, Brachial Plexus Block, Sympathetic Blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided infraclavicular brachial plexus blockProcedure or surgery
Ultrasound-guided infraclavicular brachial plexus block will be performed as part of routine clinical anesthesia practice for upper extremity surgery. Local anesthetic will be administered according to standard institutional protocols. No additional or experimental drug or procedure will be applied for research purposes. Pulse Wave Transit Time (PWTT) and other hemodynamic parameters will be recorded before and after block placement at predefined time intervals.
| Study group | Role | What they receive |
|---|---|---|
| Infraclavicular Block Group | Patients undergoing routine ultrasound-guided infraclavicular brachial plexus block for upper extremity surgery will be included in this observational cohort. Pulse Wave Transit Time (PWTT) and other hemodynamic parameters will be measured at predefined time points before and after block administration. No additional intervention beyond standard clinical care will be performed for research purposes. Receives: Procedure: Ultrasound-guided infraclavicular brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulse Wave Transit Time
The primary outcome is the time-dependent change in Pulse Wave Transit Time (PWTT) following ultrasound-guided infraclavicular brachial plexus block. PWTT will be measured as the interval between the R-wave of the electrocardiogram (ECG) and the corresponding pulse wave detected by peripheral pulse oximetry. Measurements will be recorded at baseline (pre-block) and at 0, 5, 10, 15, and 20 minutes after block placement. The primary analysis will evaluate the change in PWTT over time within the blocked extremity.
Measured: 20 minutes after infraclavicular block
Secondary outcomes (3)
Perfusion Index
Changes in perfusion index (PI) measured from the pulse oximeter at the blocked and contralateral upper extremities at baseline and at 0, 5, 10, 15, and 20 minutes after infraclavicular block.
Measured: 20 minutes after infraclavicular block
Skin Temperature
Changes in skin temperature of the blocked and contralateral upper extremities measured at baseline and at 0, 5, 10, 15, and 20 minutes after block placement.
Measured: 20 minutes after infraclavicular block
oxygen saturation
Changes in peripheral oxygen saturation measured using pulse oximetry during the study period.
Measured: 20 minutes after infraclavicular block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start26 Oct 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
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 Infraclavicular Brachial Plexus BlockStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Alaçam, MD, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669688
- Sponsor's protocol ID
- SAU-ANE-BA-04
- Status last verified
- Jul 2026
- First submitted
- 20 Jun 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi EJ, Lim JA, Choi CH, Kim DH, Jo S, Kim J. Changes in pulse wave transit time variability after interscalene brachial plexus block placement. Korean J Anesthesiol. 2026 Feb;79(1):82-94. doi: 10.4097/kja.24861. Epub 2025 May 21.
PubMed 40398868
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Dependent Changes in Pulse Wave Transit Time Following Infraclavicular Block: A Non-Invasive Assessment of Sympathetic Blockade
- ClinicalTrials.gov ID
- NCT07669688
- Acronym / sponsor ID
- SAU-ANE-BA-04
- Conditions
- Infraclavicular Brachial Plexus Block
- Keywords
- Infraclavicular Block, Pulse Wave Transit Time, Regional Anesthesia, Brachial Plexus Block, Sympathetic Blockade
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 25 Jun 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.
This prospective observational study aims to evaluate the time-dependent changes in Pulse Wave Transit Time (PWTT) following ultrasound-guided infraclavicular brachial plexus block. PWTT is a non-invasive hemodynamic parameter reflecting vascular tone and sympathetic nervous system activity. Patients undergoing upper extremity surgery under infraclavicular block will be monitored using standard perioperative monitoring devices. PWTT measurements will be obtained before and after block placement at predefined time intervals. Secondary outcomes will include perfusion index, skin temperature, heart rate, blood pressure, respiratory rate, and oxygen saturation. The study seeks to determine whether PWTT can serve as an objective and non-invasive marker of sympathetic blockade following infraclavicular block.
Detailed description
Regional anesthesia success is traditionally assessed using sensory and motor block evaluation methods that rely on patient cooperation and subjective responses to external stimuli. However, these methods may be difficult to apply in sedated, uncooperative, or communication-impaired patients. Therefore, objective and non-invasive indicators of sympathetic blockade have gained increasing interest in regional anesthesia practice.
Pulse Wave Transit Time (PWTT) is defined as the time interval between the R-wave on the electrocardiogram and the arrival of the corresponding pulse wave detected by a peripheral pulse oximeter. PWTT reflects vascular tone, arterial compliance, and hemodynamic status. Sympathetic blockade induced by peripheral nerve blocks results in vasodilation and reduced vascular resistance, potentially leading to measurable changes in PWTT. Previous studies have demonstrated the utility of objective parameters such as perfusion index, skin temperature, blood flow measurements, and PWTT in assessing block success. However, data regarding the temporal changes of PWTT following infraclavicular brachial plexus block remain limited.
The primary objective of this prospective observational study is to investigate the time-dependent changes in PWTT after ultrasound-guided infraclavicular brachial plexus block. The study will be conducted in patients undergoing upper extremity surgery under infraclavicular block at Sakarya Training and Research Hospital.
Patients scheduled to receive infraclavicular block as part of their routine clinical care will be enrolled after providing informed consent. The block procedure is not performed for research purposes and represents standard clinical practice. Following block administration, PWTT values will be recorded from the blocked extremity using standard monitoring equipment. Measurements will be obtained before block placement and at 0, 5, 10, 15, and 20 minutes after block completion. Baseline PWTT measurements will also be obtained from the contralateral upper extremity.
Secondary outcome measures will include perfusion index, skin temperature of both upper extremities, heart rate, non-invasive blood pressure, respiratory rate, and oxygen saturation. Demographic and clinical data will also be recorded.
All measurements will be collected according to a predefined protocol using standardized monitoring equipment. Since PWTT is an objective device-derived parameter, observer dependency is expected to be minimal. Data collection personnel will be separated from the clinician performing the block whenever feasible to reduce measurement bias. All collected data will be anonymized prior to statistical analysis.
This study is designed as a single-center, prospective observational investigation without randomization or intervention beyond routine clinical care. The findings may contribute to the development of PWTT as a practical, objective, and non-invasive marker of sympathetic blockade following infraclavicular brachial plexus block.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infraclavicular Block Group | – | Procedure: Ultrasound-guided infraclavicular brachial plexus blockPatients undergoing routine ultrasound-guided infraclavicular brachial plexus block for upper extremity surgery will be included in this observational cohort. Pulse Wave Transit Time (PWTT) and other hemodynamic parameters will be measured at predefined time points before and after block administration. No additional intervention beyond standard clinical care will be performed for research purposes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18-65 years with ASA physical status I who are scheduled to undergo elective upper extremity hand surgery under ultrasound-guided infraclavicular brachial plexus block. All participants will receive standard-of-care anesthesia management. Patients with contraindications to peripheral nerve block, significant systemic disease, obesity (BMI ≥30 kg/m²), coagulation disorders, opioid use, or conditions affecting sympathetic activity will be excluded. Only patients who provide informed consent will be enrolled.
Key inclusion criteria (5 listed)
- Patients undergoing elective upper extremity hand surgery
- 18 - 65 years
- ASA I
- No coagulopathy, thrombocytopenia, coagulation disorders
- Patients who provide informed consent to participate in the study
Key exclusion criteria (12 listed)
- History of drug allergy relevant to study procedures or local anesthetics
- Body mass index (BMI) ≥ 30 kg/m²
- Body weight < 40 kg
- Age < 18 years or > 65 years
- History of significant cardiac disease (e.g., arrhythmia, conduction abnormalities)
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 |
|---|---|---|
| Ultrasound-guided infraclavicular brachial plexus blockUltrasound-guided infraclavicular brachial plexus block will be performed as part of routine clinical anesthesia practice for upper extremity surgery. Local anesthetic will be administered according to standard institutional protocols. No additional or experimental drug or procedure will be applied for research purposes. Pulse Wave Transit Time (PWTT) and other hemodynamic parameters will be recorded before and after block placement at predefined time intervals. | Procedure or surgery | Infraclavicular Block Group |
Primary outcome
Change in Pulse Wave Transit Time
Time frame: 20 minutes after infraclavicular block
The primary outcome is the time-dependent change in Pulse Wave Transit Time (PWTT) following ultrasound-guided infraclavicular brachial plexus block. PWTT will be measured as the interval between the R-wave of the electrocardiogram (ECG) and the corresponding pulse wave detected by peripheral pulse oximetry. Measurements will be recorded at baseline (pre-block) and at 0, 5, 10, 15, and 20 minutes after block placement. The primary analysis will evaluate the change in PWTT over time within the blocked extremity.
3 secondary outcomes
Perfusion Index
Time frame: 20 minutes after infraclavicular block
Skin Temperature
Time frame: 20 minutes after infraclavicular block
oxygen saturation
Time frame: 20 minutes after infraclavicular block
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Results publication: PubMed 40398868Choi EJ, Lim JA, Choi CH, Kim DH, Jo S, Kim J. Changes in pulse wave transit time variability after interscalene brachial plexus block placement. Korean J Anesthesiol. 2026 Feb;79(1):82-94. doi: 10.4097/kja.24861. Epub 2025 May 21.
- Individual participant dataSharing planned: No
Related trials for Infraclavicular Brachial Plexus Block
Not yet recruitingObservational study
Body Mass Index and Outcomes of Ultrasound-Guided Infraclavicular Brachial Plexus Block
Obesity (BMI>30)
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
Recruiting
Comparison Between Ultrasound-Guided Costoclavicular and Lateral-Sagittal Infraclavicular Brachial Plexus Blocks in Adult Distal Upper Limb Surgeries
Regional Anesthesia Block, Brachial Plexus Blocks
Recruiting
Diaphragm-Sparing Regional Anesthesia Techniques for Shoulder Surgery
Osteoarthritis Shoulder
Recruiting
Comparison of Conventional and Retroclavicular Approaches for Ultrasound-guided Infraclavicular Brachial Plexus Block
Peripheral Nerve Block, Pain Management
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infraclavicular Brachial Plexus Block, run by Sakarya University at 2 sites 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 12 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: looking for participants now, as of the sponsor's last update on 28 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burçin Alaçam (+905465903851, burcin.ersoy90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulse Wave Transit Time (time frame: 20 minutes after infraclavicular block). 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 NCT07669688, 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 28 Oct 2026.