Regional Anesthesia, Interscalene Blocks, Shoulder Surgery, Perfusion Index
Conditions
Keywords
shoulder surgery, Perfusion index, regional oxygen saturation
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.
Interventions
PROCEDUREGeneral 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.
PROCEDUREInterscalene 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.
Sponsors
Sakarya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Diagnostic/Physiological Evaluation
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brachial Artery Flow Volume | 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
| Measure | Time frame | Description |
|---|---|---|
| Forearm Tissue Oxygenation and Perfusion | 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. |
| Perfusion Index (PI) | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORHalil Kızılışık, Specialist
Sakarya University Training and Research Hospital
STUDY_DIRECTOROnur Palabıyık, Assoc. Prof.
Sakarya University Training and Research Hospital
STUDY_CHAIRÖzge Pekşen Kızılışık, Specialist
Sakarya University Training and Research Hospital
STUDY_CHAIRMuhammed Halit tekeci, Specialist
Sakarya University Training and Research Hospital
Outcome results
None listed