Peripheral Nerve BlockPI-FSNBNCT07507227
Perfusion Index for Assessing Femoral and Sciatic Nerve Block Success in Lower Extremity Surgery
A study testing Combined Femoral and Sciatic Nerve Block in people with Peripheral Nerve Block, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Peripheral nerve blocks are increasingly used in lower extremity surgery as an alternative to general anesthesia. However, traditional methods used to assess block success, such as sensory and motor testing, are subjective, time-consuming, and dependent on patient cooperation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Nerve Block
- What is being tested?
- Combined Femoral and Sciatic Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 31 Jan 2019
- 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
- ASA physical status I-III
- Scheduled for elective lower extremity surgery
- Patients undergoing combined femoral and sciatic nerve block
- Ability to provide informed consent
Who cannot join
- Patient refusal
- Infection at the injection site
- Known allergy to local anesthetic agents
- Coagulopathy or bleeding disorders
- Pre-existing neurological deficits in the lower extremities
- Severe systemic disease (ASA IV and above)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University Faculty of Medicine
Gaziantep
About this study
Official title: Evaluation of Femoral and Sciatic Nerve Block Success Using Perfusion Index Measurement in Patients Undergoing Lower Extremity Surgery
Peripheral nerve blocks are increasingly used in lower extremity surgery as an alternative to general anesthesia. However, traditional methods used to assess block success, such as sensory and motor testing, are subjective, time-consuming, and dependent on patient cooperation.
The perfusion index (PI), measured non-invasively using pulse oximetry, reflects peripheral perfusion changes associated with sympathetic blockade and may serve as an early indicator of block effectiveness.
Read more
This study aims to evaluate whether PI can be used as an early and reliable marker for assessing the success of combined femoral and sciatic nerve block in patients undergoing elective lower extremity surgery.
A total of 80 patients aged 18-65 years with ASA physical status I-III will receive ultrasound- and nerve stimulator-guided combined femoral and sciatic nerve block. Hemodynamic parameters and perfusion-related variables, including PI, capillary refill time, and skin temperature, will be recorded at baseline and at 5, 10, 20, and 30 minutes after block administration.
The results will be compared with traditional sensory and motor block assessments to determine whether PI provides an earlier and objective assessment of block success.
Read the detailed description
Peripheral nerve blocks are widely used in lower extremity surgery due to their advantages over general anesthesia, including reduced systemic complications and improved postoperative analgesia. The success of a nerve block is traditionally evaluated using sensory and motor block assessments; however, these methods are subjective and require patient cooperation.
Perfusion index (PI), measured non-invasively using pulse oximetry, reflects peripheral perfusion and is influenced by sympathetic blockade. Following a successful nerve block, sympathetic nerve inhibition leads to vasodilation and increased peripheral blood flow, which may result in an increase in PI.
This prospective clinical study includes 80 patients aged 18-65 years with ASA physical status I-III scheduled for elective lower extremity surgery. All patients receive combined femoral and sciatic nerve block using ultrasound guidance and nerve stimulation techniques. For the sciatic block, 30 mL of a mixture of 0.25% bupivacaine and 1% lidocaine is administered, and for the femoral block, 20 mL of the same solution is used.
Hemodynamic parameters, including heart rate, mean arterial pressure, and oxygen saturation, as well as perfusion-related parameters such as perfusion index, capillary refill time, and distal skin temperature, are recorded at baseline and at 5, 10, 20, and 30 minutes after block administration. Sensory and motor block assessments are performed using cold sensation, pin-prick test, and motor block scales.
The primary objective is to evaluate whether PI can serve as an early, objective, and non-invasive indicator of block success compared to traditional assessment methods.
- Conditions
- Peripheral Nerve Block
- Being tested
- Combined Femoral and Sciatic Nerve Block
- Keywords
- Perfusion Index, Femoral Nerve Block, Sciatic Nerve Block, Peripheral Nerve Block, Regional Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Femoral and Sciatic Nerve BlockProcedure or surgery
Ultrasound- and nerve stimulator-guided femoral and sciatic nerve block performed using a mixture of bupivacaine and lidocaine for anesthesia in lower extremity surgery.
| Study group | Role | What they receive |
|---|---|---|
| Combined Femoral and Sciatic Nerve Block | Experimental | All participants receive ultrasound- and nerve stimulator-guided combined femoral and sciatic nerve block prior to lower extremity surgery. Receives: Procedure: Combined Femoral and Sciatic Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perfusion Index Following Nerve Block
Perfusion index values measured at predefined time intervals after combined femoral and sciatic nerve block and compared with baseline and contralateral limb values.
Measured: Baseline, 5, 10, 20, and 30 minutes after block administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jun 2018
- Primary completion1 Sep 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve BlockStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group interventional study in which all participants receive combined femoral and sciatic nerve block. Perfusion index and conventional block assessment methods are measured and compared over time to evaluate block success.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Kaya Ugur, University of Gaziantep
- Investigators
- Berna Kaya Uğur, Principal investigator, Gaziantep University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507227
- Sponsor's protocol ID
- GAZ-PI-BLOCK-2019
- Acronym
- PI-FSNB
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Femoral and Sciatic Nerve Block Success Using Perfusion Index Measurement in Patients Undergoing Lower Extremity Surgery
- ClinicalTrials.gov ID
- NCT07507227
- Acronym / sponsor ID
- PI-FSNB / GAZ-PI-BLOCK-2019
- Conditions
- Peripheral Nerve Block
- Keywords
- Perfusion Index, Femoral Nerve Block, Sciatic Nerve Block, Peripheral Nerve Block, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 2 Apr 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.
Peripheral nerve blocks are increasingly used in lower extremity surgery as an alternative to general anesthesia. However, traditional methods used to assess block success, such as sensory and motor testing, are subjective, time-consuming, and dependent on patient cooperation.
The perfusion index (PI), measured non-invasively using pulse oximetry, reflects peripheral perfusion changes associated with sympathetic blockade and may serve as an early indicator of block effectiveness.
This study aims to evaluate whether PI can be used as an early and reliable marker for assessing the success of combined femoral and sciatic nerve block in patients undergoing elective lower extremity surgery.
A total of 80 patients aged 18-65 years with ASA physical status I-III will receive ultrasound- and nerve stimulator-guided combined femoral and sciatic nerve block. Hemodynamic parameters and perfusion-related variables, including PI, capillary refill time, and skin temperature, will be recorded at baseline and at 5, 10, 20, and 30 minutes after block administration.
The results will be compared with traditional sensory and motor block assessments to determine whether PI provides an earlier and objective assessment of block success.
Detailed description
Peripheral nerve blocks are widely used in lower extremity surgery due to their advantages over general anesthesia, including reduced systemic complications and improved postoperative analgesia. The success of a nerve block is traditionally evaluated using sensory and motor block assessments; however, these methods are subjective and require patient cooperation.
Perfusion index (PI), measured non-invasively using pulse oximetry, reflects peripheral perfusion and is influenced by sympathetic blockade. Following a successful nerve block, sympathetic nerve inhibition leads to vasodilation and increased peripheral blood flow, which may result in an increase in PI.
This prospective clinical study includes 80 patients aged 18-65 years with ASA physical status I-III scheduled for elective lower extremity surgery. All patients receive combined femoral and sciatic nerve block using ultrasound guidance and nerve stimulation techniques. For the sciatic block, 30 mL of a mixture of 0.25% bupivacaine and 1% lidocaine is administered, and for the femoral block, 20 mL of the same solution is used.
Hemodynamic parameters, including heart rate, mean arterial pressure, and oxygen saturation, as well as perfusion-related parameters such as perfusion index, capillary refill time, and distal skin temperature, are recorded at baseline and at 5, 10, 20, and 30 minutes after block administration. Sensory and motor block assessments are performed using cold sensation, pin-prick test, and motor block scales.
The primary objective is to evaluate whether PI can serve as an early, objective, and non-invasive indicator of block success compared to traditional assessment methods.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group interventional study in which all participants receive combined femoral and sciatic nerve block. Perfusion index and conventional block assessment methods are measured and compared over time to evaluate block success.
| Arm | Type | Receives |
|---|---|---|
| Combined Femoral and Sciatic Nerve Block | Experimental | Procedure: Combined Femoral and Sciatic Nerve BlockAll participants receive ultrasound- and nerve stimulator-guided combined femoral and sciatic nerve block prior to lower extremity surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 18 and 65 years
- ASA physical status I-III
- Scheduled for elective lower extremity surgery
- Patients undergoing combined femoral and sciatic nerve block
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Patient refusal
- Infection at the injection site
- Known allergy to local anesthetic agents
- Coagulopathy or bleeding disorders
- Pre-existing neurological deficits in the lower extremities
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 |
|---|---|---|
| Combined Femoral and Sciatic Nerve BlockUltrasound- and nerve stimulator-guided femoral and sciatic nerve block performed using a mixture of bupivacaine and lidocaine for anesthesia in lower extremity surgery. | Procedure or surgery | Combined Femoral and Sciatic Nerve Block |
Primary outcome
Change in Perfusion Index Following Nerve Block
Time frame: Baseline, 5, 10, 20, and 30 minutes after block administration
Perfusion index values measured at predefined time intervals after combined femoral and sciatic nerve block and compared with baseline and contralateral limb values.
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 2 Apr 2026.
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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.
Berna Kaya Uğur principal investigator
Gaziantep University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Femoral and Sciatic Nerve Block in people with Peripheral Nerve Block, run by University of Gaziantep 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 5 inclusion and 6 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 2 Apr 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?
Change in Perfusion Index Following Nerve Block (time frame: Baseline, 5, 10, 20, and 30 minutes after block administration). 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 2 Apr 2026.