NCT07326436

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

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2023

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

April 10, 2023

Last Update Submit

January 3, 2026

Conditions

Keywords

supraclavicular brachial plexus blockperfusion indexskin temperatureinfraclavicular brachial plexus blocksympathetic blockade

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 COMPARATOR
Procedure: Supraclavicular brachial plexus block

Infraclavicular brachial plexus block

ACTIVE COMPARATOR
Procedure: Infraclavicular brachial plexus block

Interventions

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.

Infraclavicular 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.

Supraclavicular brachial plexus block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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

Locations