- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07326436
Comparison of Sympathetic Blockade Duration in Brachial Plexus Blocks Performed by Different Methods
January 3, 2026 updated by: Pelin Doğan Uzun, Bozyaka Training and Research Hospital
Comparison of Sympathetic Block Duration and Rebound Sympathetic Activity Rate in Infraclavicular and Supraclavicular Brachial Plexus Blocks Using Perfusion Index and Skin Temperature
This prospective comparative study will evaluate the sympathetic effects of ultrasound-guided infraclavicular versus supraclavicular brachial plexus blocks in adults undergoing upper-extremity surgery.
Sympathetic tone will be monitored noninvasively with simultaneous bilateral measurements of perfusion index (pulse-oximetry-derived) and skin temperature obtained at baseline and at predefined post-block intervals until return to baseline.
The primary outcome is the duration of sympathetic block.
Secondary outcomes are between-approach differences in the time course of perfusion index and skin temperature, and the incidence and magnitude of rebound sympathetic activity.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
İzmir
-
Izmir, İzmir, Turkey (Türkiye), 35030
- Bozyaka Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 to 65 year old
- ASA I-II
- Patients scheduled for upper extremity surgery
- Fully oriented and able to cooperate
- Patients who signed the informed consent form and gave consent to participate in the study
Exclusion Criteria:
- ASA III-IV-V
- Non-cooperation
- Disease that interferes with sensory block assessment
- Known allergy to the medicines to be used
- Pregnant patients
- Coagulopathy or thrombocytopenia
- Patients with anatomical abnormalities or active infection at the points of application
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Supraclavicular brachial plexus block
|
A linear US probe (7-13 MHz) will be placed in the supraclavicular area in the coronal oblique plane, in-plane technique will be used, and after antisepsis of the area to be blocked, injection will be performed from lateral to medial direction using a 22G 50 mm stimulator needle (Stimuplex A®: B. Braun Melsungen AG, Japan).
Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.
A total of 30 mL of 2% prilocaine containing 0.5% bupivacaine and 5 mcg/mL adrenaline in a 1:1 ratio will be used as local anesthetic.
|
|
Active Comparator: Infraclavicular brachial plexus block
|
A linear US probe (7-13 MHz) will be placed in the infraclavicular area through a lateral sagittal approach, in plane technique will be used and injection will be performed using a 22G 100 mm stimulator needle (Stimuplex A®: B. Braun Melsungen AG, Japan) after antisepsis of the area to be blocked.
Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.
A total of 30 mL of 2% prilocaine containing 0.5% bupivacaine and 5 mcg/mL adrenaline in a 1:1 ratio will be used as local anesthetic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Difference in duration of sympathetic blockade after different US-guided brachial plexus blocks
Time Frame: Twenty-four hours after nerve blockage
|
Twenty-four hours after nerve blockage
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in perfusion index between infraclavicular and supraclavicular approaches
Time Frame: Twenty-four hours after nerve blockage
|
The perfusion index measured by pulse oximetry will be recorded at baseline and twenty-four hours after brachial plexus block.
The outcome measure is defined as the change in perfusion index value between the two time points and compared between block approaches.
|
Twenty-four hours after nerve blockage
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
September 2, 2023
Study Registration Dates
First Submitted
April 10, 2023
First Submitted That Met QC Criteria
January 3, 2026
First Posted (Actual)
January 8, 2026
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
January 3, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Brachial Plexus Block
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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