Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Forearm Tissue Oxygenation and Perfusion | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sakarya University Training and Research Hospital | Sakarya | 54000 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Diagnostic/Physiological Evaluation
Not provided
Not provided
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.
|
| 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. |
|
|
| Perfusion Index (PI) | 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. |