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Completed

NCT Number: NCT07449611

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

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.

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Key information

Conditions

Regional Anesthesia Interscalene Blocks Perfusion Index Shoulder Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University Training and Research Hospital

Sakarya, 54000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General Aneasthesia

Procedure

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

interscalene block

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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