NCT07669688

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress11%
Jul 2026Nov 2026

First Submitted

Initial submission to the registry

June 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

July 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 20, 2026

Last Update Submit

July 4, 2026

Conditions

Keywords

Infraclavicular BlockPulse Wave Transit TimeRegional AnesthesiaBrachial Plexus BlockSympathetic Blockade

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 minutes after infraclavicular block

Secondary Outcomes (3)

  • Perfusion Index

    20 minutes after infraclavicular block

  • Skin Temperature

    20 minutes after infraclavicular block

  • oxygen saturation

    20 minutes after infraclavicular block

Study Arms (1)

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.

Procedure: Ultrasound-guided infraclavicular brachial plexus block

Interventions

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.

Infraclavicular Block Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients undergoing elective upper extremity hand surgery
  • years
  • ASA I
  • No coagulopathy, thrombocytopenia, coagulation disorders
  • Patients who provide informed consent to participate in the study

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University-Anesthesiology and Reanimation Department

Sakarya, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 20, 2026

First Posted

June 25, 2026

Study Start

July 20, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations