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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sakarya University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Brachial Artery Flow Volume
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: General Aneasthesia (Procedure)
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.
Intervention: Interscalene block (Procedure)
Outcomes
Primary Outcomes
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
- 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.)
Investigators
halil kızılışık
Anesthesiology and Reanimation Specialist, M.D.
Sakarya University