Comparison of Sympathetic Blockade Duration in Brachial Plexus Blocks Performed by Different Methods
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
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 Start
First participant enrolled
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2026
CompletedJanuary 8, 2026
January 1, 2026
6 months
April 10, 2023
January 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in duration of sympathetic blockade after different US-guided brachial plexus blocks
Twenty-four hours after nerve blockage
Secondary Outcomes (1)
Change in perfusion index between infraclavicular and supraclavicular approaches
Twenty-four hours after nerve blockage
Study Arms (2)
Supraclavicular brachial plexus block
ACTIVE COMPARATORInfraclavicular brachial plexus block
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bozyaka Training and Research Hospital
Izmir, İzmir, 35030, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor of medicine
Study Record Dates
First Submitted
April 10, 2023
First Posted
January 8, 2026
Study Start
March 1, 2023
Primary Completion
September 1, 2023
Study Completion
September 2, 2023
Last Updated
January 8, 2026
Record last verified: 2026-01