Comparative Impacts of Two Anesthesia Methods on Peripheral Tissue Oxygenation in the Upper Limb

March 1, 2026 updated by: halil kızılışık, Sakarya University

COMPARISON OF THE EFFECTS OF GENERAL ANESTHESIA AND INTERSCALENE BLOCK ON BRACHIAL ARTERY BLOOD VOLUME FLOW, PERFUSION INDEX AND PERIPHERAL REGIONAL TISSUE OXYGENATION IN UPPER EXTREMITY SURGERY

This study will aim to compare the effects of two different anesthesia techniques-general anesthesia (GA) and interscalene brachial plexus block (ISB)-on forearm tissue oxygenation in patients undergoing shoulder surgery. A total of 49 patients aged 18 to 65 will be enrolled. After standard monitoring, a pulse oximeter will be placed on the second finger of the operative limb, and a regional oxygen saturation (rSO₂) sensor will be applied to the forearm to measure the perfusion index (PI) and rSO₂.

Brachial artery parameters will be evaluated using ultrasound imaging approximately 2-3 cm proximal to the antecubital fossa. Patients will be assigned to either the GA group (Group 1) or the ISB group (Group 2). Mean arterial pressure (MAP), heart rate (HR), peripheral oxygen saturation (SpO₂), flow volume (FV), brachial artery diameter (BAD), and near-infrared spectroscopy (NIRS) variables (rSO₂, ΔcHbi, ΔO₂Hbi, ΔHHbi), along with PI values, will be recorded at baseline (before the procedure) and at 10, 20, 30, and 60 minutes following the completion of the block procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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

  • Turkey (Türkiye)
      • Sakarya, Turkey (Türkiye), 54000
        • Sakarya University 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:

  • Patients aged between 18 and 65 years
  • Undergoing shoulder surgery between December 15, 2023, and March 15, 2024
  • Provided written informed consent to participate in the study

Exclusion Criteria:

  • Patients who refuse to participate in the study
  • American Society of Anesthesiology (ASA) physical status classification of III or IV and above
  • Contraindications to interscalene block
  • Inability to cooperate during the procedure
  • Patients with renal failure
  • Patients with hepatic failure
  • Pregnant or breastfeeding women

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group GA
Participants in this group will receive general anesthesia using standard induction and maintenance protocols. No regional block will be administered. Hemodynamic parameters, brachial artery flow, and tissue oxygenation values will be monitored throughout the procedure.
Procedure: General Aneasthesia
General anesthesia will be administered using standard intravenous induction agents (e.g., propofol, fentanyl) and maintenance with inhalational agents as per institutional protocols. No regional block will be performed.
Other Names:
  • GA
Active Comparator: Group ISB
Participants in this group will receive an ultrasound-guided interscalene brachial plexus block as the sole anesthesia technique. No general anesthesia will be administered. Hemodynamic parameters, brachial artery flow, and tissue oxygenation values will be monitored throughout the procedure.
Procedure: Interscalene block
An ultrasound-guided interscalene brachial plexus block will be performed as the sole anesthesia technique. Local anesthetic will be injected around the brachial plexus roots at the level of the interscalene groove to provide regional anesthesia for shoulder surgery.
Other Names:
  • ISB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brachial Artery Flow Volume
Time Frame: Baseline, and at 10, 20, 30, and 60 minutes after block completion.
Flow volume of the brachial artery will be measured using ultrasound to evaluate changes in blood flow during and after anesthesia.
Baseline, and at 10, 20, 30, and 60 minutes after block completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forearm Tissue Oxygenation and Perfusion
Time Frame: Baseline (pre-procedure), and at 10, 20, 30, and 60 minutes after block completion.
Regional oxygen saturation (rSO₂) and near-infrared spectroscopy (NIRS) parameters-namely, changes in total hemoglobin (ΔcHb), oxygenated hemoglobin (ΔO₂Hb), and deoxygenated hemoglobin (ΔHHb)-will be measured using a single, unified NIRS-based platform to assess tissue oxygenation and perfusion.
Baseline (pre-procedure), and at 10, 20, 30, and 60 minutes after block completion.
Perfusion Index (PI)
Time Frame: Baseline, and at 10, 20, 30, and 60 minutes after block completion.
Perfusion index values will be recorded to evaluate peripheral tissue perfusion changes during and after anesthesia.
Baseline, and at 10, 20, 30, and 60 minutes after block completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Investigators

  • Principal Investigator: Halil Kızılışık, Specialist, Sakarya University Training and Research Hospital
  • Study Director: Onur Palabıyık, Assoc. Prof., Sakarya University Training and Research Hospital
  • Study Chair: Özge Pekşen Kızılışık, Specialist, Sakarya University Training and Research Hospital
  • Study Chair: Muhammed Halit tekeci, Specialist, Sakarya University Training and Research Hospital

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)

December 15, 2023

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

July 17, 2025

First Submitted That Met QC Criteria

March 1, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-16214662-050.01.04-310641169

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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