AdultNCT06372691
How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block?
A study testing Subparaneural Injection (Grup S), Block and Interneural Injection (Grup I), Block in people with Adult and Regional Anesthesia Morbidity, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult, Regional Anesthesia Morbidity, Anesthesia Injection Site
- What is being tested?
- Subparaneural Injection (Grup S), Block and Interneural Injection (Grup I), Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Apr 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over
- Planned foot, ankle or toe amputation
- ASA III-IV risk group
- Patients who agreed to be included in the study
Who cannot join
- People with neurological and psychiatric diseases
- Using opioids or another analgesic for chronic pain
- Allergic to local anesthetics
- Pregnant or breastfeeding
- Those with infection or sepsis in the application area
- Patients who did not agree to be included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06000
About this study
Official title: How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block;Is It Injection Subparaneural, Interneural?
The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks.
Read the detailed description
The study will involve American Society of Anesthesiologists Physical Status Classification (ASA) III or IV risk group patients, 18 years of age or older, who will undergoing foot, ankle, or toe amputation.
Supparaneural injection (Group S) and interneural injection method (Group I) will the two research groups to which patients were randomly allocated.
Every 5 minutes following LA injection, an investigator who will blind to randomization will assess the sensory and motor blockage in the operated foot. The study will documented the operative time, block characteristics, such as the duration of block administration, sensory and motor block start and regression times, the time of extra analgesic required, and the occurrence of complications.
- Being tested
- Subparaneural Injection (Grup S), Block, Interneural Injection (Grup I), Block
- Keywords
- Popliteal Approach Sciatic Nerve Block, Regional Anesthesia, Foot, Ankle and Toe Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subparaneural Injection (Grup S), BlockOther
Comparison of two different methods in terms of various features
Interneural Injection (Grup I), BlockOther
Comparison of two different methods in terms of various features
| Study group | Role | What they receive |
|---|---|---|
| Subparaneural Injection (Group S) | Active comparator | The position of the patients will be prone.The skin will be cleaned according to asepsis and antisepsis rules.After preparing the USG a high-frequency linear array transducer under sterile conditions,we will be positioned it transversely in the popliteal fossa.After visualizing the artery,its hyperechoic nerves will be founded superficially.The sciatic nerve will be identified proximally to visualize where the TN and CPN eventually come together to form the sciatic nerve and separate distally where the CPN moves laterally and the TN remains medially.Once the nerves began to separate,they will be scanned until a figure 8 or pant leg image will be obtained.Using the in-plane technique under ultrasonography guidance, injection will be applied to the subparaneural area in Group S.1 ml of LA solution was injected for the purpose of verifying proper needle insertion.A standard dose of 15 mL bupivacaine 0.5% and 5mg/mL local anesthetic was used accompanied by a 20G,12mm block needle. Receives: Other: Subparaneural Injection (Grup S), Block |
| Interneural Injection (Group I) | Active comparator | The position of the patients will be prone.The skin will be cleaned according to asepsis and antisepsis rules.After preparing the USG a high-frequency linear array transducer under sterile conditions, we will be positioned it transversely in the popliteal fossa.After visualizing the artery, its hyperechoic nerves will be founded superficially.The sciatic nerve will be identified proximally to visualize where the TN and CPN eventually come together to form the sciatic nerve and separate distally where the CPN moves laterally and the TN remains medially.Once the nerves began to separate, they will be scanned until a figure 8 or pant leg image will be obtained.Using the in-plane technique under ultrasonography guidance, injection will be applied to the interneural area in Group I.1 ml of LA solution was injected for the purpose of verifying proper needle insertion.A standard dose of 15 mL bupivacaine 0.5% and 5mg/mL local anesthetic was used accompanied by a 20 G, 12mm block needle. Receives: Other: Interneural Injection (Grup I), Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset Time
Onset time will be defined as the moment when it is determined that the block is successful.
Measured: Time from the moment the block is made to the moment it starts, within the first half hour
Secondary outcomes (9)
Block Execution Times
The time from the moment the block starts to the moment the transaction ends.
Measured: 1-10 minutes
Need for Multiple Injections Owing to Insufficient Anesthesia
How many blocks should be made.
Measured: Within 24 hours
Additional Rescue Analgesic
Analgesic use status.
Measured: Within 24 hours
Adverse Effects to Anesthesia
hypotension, agitation, nausea, vomiting, dizziness
Measured: During the block period, within 24 hours
Hemodynamic Effects Of The Block
Noninvasive systolic and diastolic blood pressure
Measured: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Effects Of The Block On Heart Rate
Heart rate
Measured: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Effects Of The Block On Peripheral Pulse Oximetry
Peripheral pulse oximetry
Measured: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Regression Time Of Sensory and Motor Block
When the block starts to come back.
Measured: Within 24 hours
Total Block Times
How long the block took in total.
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024
- Primary completion1 Feb 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, semih başkan, Ankara City Hospital Bilkent
- Investigators
- Semih Başkan, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372691
- Sponsor's protocol ID
- PoplitealApproach SciaticBlock
- Status last verified
- Sep 2024
- First submitted
- 1 Apr 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block;Is It Injection Subparaneural, Interneural?
- ClinicalTrials.gov ID
- NCT06372691
- Acronym / sponsor ID
- PoplitealApproach SciaticBlock
- Keywords
- Popliteal Approach Sciatic Nerve Block, Regional Anesthesia, Foot, Ankle and Toe Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 18 Apr 2024 (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.
The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks.
Detailed description
The study will involve American Society of Anesthesiologists Physical Status Classification (ASA) III or IV risk group patients, 18 years of age or older, who will undergoing foot, ankle, or toe amputation.
Supparaneural injection (Group S) and interneural injection method (Group I) will the two research groups to which patients were randomly allocated.
Every 5 minutes following LA injection, an investigator who will blind to randomization will assess the sensory and motor blockage in the operated foot. The study will documented the operative time, block characteristics, such as the duration of block administration, sensory and motor block start and regression times, the time of extra analgesic required, and the occurrence of complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subparaneural Injection (Group S) | Active comparator | Other: Subparaneural Injection (Grup S), BlockThe position of the patients will be prone.The skin will be cleaned according to asepsis and antisepsis rules.After preparing the USG a high-frequency linear array transducer under sterile conditions,we will be positioned it transversely in the popliteal fossa.After visualizing the artery,its hyperechoic nerves will be founded superficially.The sciatic nerve will be identified proximally to visualize where the TN and CPN eventually come together to form the sciatic nerve and separate distally where the CPN moves laterally and the TN remains medially.Once the nerves began to separate,they will be scanned until a figure 8 or pant leg image will be obtained.Using the in-plane technique under ultrasonography guidance, injection will be applied to the subparaneural area in Group S.1 ml of LA solution was injected for the purpose of verifying proper needle insertion.A standard dose of 15 mL bupivacaine 0.5% and 5mg/mL local anesthetic was used accompanied by a 20G,12mm block needle. |
| Interneural Injection (Group I) | Active comparator | Other: Interneural Injection (Grup I), BlockThe position of the patients will be prone.The skin will be cleaned according to asepsis and antisepsis rules.After preparing the USG a high-frequency linear array transducer under sterile conditions, we will be positioned it transversely in the popliteal fossa.After visualizing the artery, its hyperechoic nerves will be founded superficially.The sciatic nerve will be identified proximally to visualize where the TN and CPN eventually come together to form the sciatic nerve and separate distally where the CPN moves laterally and the TN remains medially.Once the nerves began to separate, they will be scanned until a figure 8 or pant leg image will be obtained.Using the in-plane technique under ultrasonography guidance, injection will be applied to the interneural area in Group I.1 ml of LA solution was injected for the purpose of verifying proper needle insertion.A standard dose of 15 mL bupivacaine 0.5% and 5mg/mL local anesthetic was used accompanied by a 20 G, 12mm block needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and over
- Planned foot, ankle or toe amputation
- ASA III-IV risk group
- Patients who agreed to be included in the study
Key exclusion criteria (6 listed)
- People with neurological and psychiatric diseases
- Using opioids or another analgesic for chronic pain
- Allergic to local anesthetics
- Pregnant or breastfeeding
- Those with infection or sepsis in the application area
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 |
|---|---|---|
| Subparaneural Injection (Grup S), BlockComparison of two different methods in terms of various features | Other | Subparaneural Injection (Group S) |
| Interneural Injection (Grup I), BlockComparison of two different methods in terms of various features | Other | Interneural Injection (Group I) |
Primary outcome
Onset Time
Time frame: Time from the moment the block is made to the moment it starts, within the first half hour
Onset time will be defined as the moment when it is determined that the block is successful.
9 secondary outcomes
Block Execution Times
Time frame: 1-10 minutes
Need for Multiple Injections Owing to Insufficient Anesthesia
Time frame: Within 24 hours
Additional Rescue Analgesic
Time frame: Within 24 hours
Adverse Effects to Anesthesia
Time frame: During the block period, within 24 hours
Hemodynamic Effects Of The Block
Time frame: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Effects Of The Block On Heart Rate
Time frame: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Effects Of The Block On Peripheral Pulse Oximetry
Time frame: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Regression Time Of Sensory and Motor Block
Time frame: Within 24 hours
Total Block Times
Time frame: Within 24 hours
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 20 Jul 2025.
Related trials for Adult
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
Active, not recruitingPhase 3
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Not yet recruiting
Short, Wordless Animated Storytelling to Promote Mental Health Help-Seeking in Young Adults: A U.S. Online Randomized Controlled Trial
Mental Health Help-Seeking
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.
Semih Başkan principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subparaneural Injection (Grup S), Block and Interneural Injection (Grup I), Block in people with Adult and Regional Anesthesia Morbidity, run by Ankara City Hospital Bilkent 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 4 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 20 Jul 2025. 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?
Onset Time (time frame: Time from the moment the block is made to the moment it starts, within the first half hour). 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 20 Jul 2025.