Regional AnesthesiaNCT07449611
Comparative Impacts of Two Anesthesia Methods on Peripheral Tissue Oxygenation in the Upper Limb
A study testing General Aneasthesia and Interscalene block in people with Regional Anesthesia and Interscalene Blocks, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Regional Anesthesia, Interscalene Blocks, Shoulder Surgery
- What is being tested?
- General Aneasthesia and Interscalene block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Sakarya, 54000
About this study
Official 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
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.
- Being tested
- General Aneasthesia, Interscalene block
- Keywords
- shoulder surgery, Perfusion index, regional oxygen saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AneasthesiaProcedure or surgery
Also called GA
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.
Interscalene blockProcedure or surgery
Also called ISB
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Interscalene block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, and at 10, 20, 30, and 60 minutes after block completion.
Secondary outcomes (2)
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.
Measured: Baseline (pre-procedure), and at 10, 20, 30, and 60 minutes after block completion.
Perfusion Index (PI)
Perfusion index values will be recorded to evaluate peripheral tissue perfusion changes during and after anesthesia.
Measured: Baseline, and at 10, 20, 30, and 60 minutes after block completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start15 Dec 2023
- Primary completion15 Mar 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Diagnostic/Physiological Evaluation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, halil kızılışık, Sakarya University
- Investigators
- Halil Kızılışık, Specialist, Principal investigator, Sakarya University Training and Research HospitalOnur Palabıyık, Assoc. Prof., Study director, Sakarya University Training and Research HospitalÖzge Pekşen Kızılışık, Specialist, Study chair, Sakarya University Training and Research HospitalMuhammed Halit tekeci, Specialist, Study chair, Sakarya University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449611
- Sponsor's protocol ID
- E-16214662-050.01.04-310641169
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07449611
- Acronym / sponsor ID
- E-16214662-050.01.04-310641169
- Keywords
- shoulder surgery, Perfusion index, regional oxygen saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Diagnostic/Physiological Evaluation
| Arm | Type | Receives |
|---|---|---|
| Group GA | Active comparator | Procedure: General AneasthesiaParticipants 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 | Procedure: Interscalene blockParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General AneasthesiaAlso: GAGeneral 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. | Procedure or surgery | Group GA |
| Interscalene blockAlso: ISBAn 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. | Procedure or surgery | Group ISB |
Primary outcome
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.
2 secondary outcomes
Forearm Tissue Oxygenation and Perfusion
Time frame: Baseline (pre-procedure), and at 10, 20, 30, and 60 minutes after block completion.
Perfusion Index (PI)
Time frame: Baseline, and at 10, 20, 30, and 60 minutes after block completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Regional Anesthesia
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Recruiting
Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient
Pregnancy
RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
Infraclavicular Brachial Plexus Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halil Kızılışık, Specialist principal investigator
Sakarya University Training and Research Hospital
Onur Palabıyık, Assoc. Prof. study director
Sakarya University Training and Research Hospital
Özge Pekşen Kızılışık, Specialist study chair
Sakarya University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Aneasthesia and Interscalene block in people with Regional Anesthesia and Interscalene Blocks, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Artery Flow Volume (time frame: Baseline, and at 10, 20, 30, and 60 minutes after block completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.