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

NCT07449611 | Completed

• 1 other identifier: E-16214662-050.01.04-310641169
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Regional Anesthesia; Interscalene Blocks; Shoulder Surgery; Perfusion Index

Keywords

shoulder surgery; Perfusion index; regional oxygen saturation

Outcome Measures

Primary Outcomes (1)

• Brachial Artery Flow Volume

  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 Outcomes (2)

• Forearm Tissue Oxygenation and Perfusion

  Baseline (pre-procedure), and at 10, 20, 30, and 60 minutes after block completion.

• Perfusion Index (PI)

  Baseline, and at 10, 20, 30, and 60 minutes after block completion.

Study Arms (2)

Group GA

ACTIVE COMPARATOR

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

Group ISB

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: GA

Group 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.

Also known as: ISB

Group ISB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University Training and Research Hospital

Sakarya, 54000, Turkey (Türkiye)

Location

Study Officials

• Halil Kızılışık, Specialist

  Sakarya University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Onur Palabıyık, Assoc. Prof.

  Sakarya University Training and Research Hospital

  STUDY DIRECTOR

• Özge Pekşen Kızılışık, Specialist

  Sakarya University Training and Research Hospital

  STUDY CHAIR

• Muhammed Halit tekeci, Specialist

  Sakarya University Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the individual performing outcome measurements (MAP, HR, SpO₂, NIRS, PI, and ultrasound-based parameters) will be blinded to group assignments to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist, M.D.

Model Details: Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Diagnostic/Physiological Evaluation

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: March 4, 2026
• Study Start: December 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: June 15, 2024
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

TU (1)