AnesthesiaNCT06076096
SIFIB As an Anesthesia Method for Lower Extremity Surgeries
An observational study of Anesthesia and Anesthesia Management, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
The Ultrasound-guided Supra-inguinal Fascia Iliaca Block (SIFIB) is an advanced regional anesthesia technique strategically directed at the three primary nerves of the lumbar plexus. As the scope of regional anesthesia methods continues to grow in clinical application, this approach emerges as a versatile method. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anesthesia, Anesthesia Management, Regional Anesthesia
- What is being tested?
- Suprainguinal fascia iliaca block
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 15 Mar 2023
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Specifically, we included patients who underwent SIFIB either as the primary anesthesia method or as a component of the anesthesia plan.
Who may be able to join
- ASA I-III patients who underwent elective lower limb surgical procedures.
Who cannot join
- Patients who received general anesthesia, neuraxial anesthesia, or infiltration anesthesia were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Supra-Inguinal Fascia Iliaca Block As an Anesthesia Method for Lower Extremity Surgeries: A Single-Center Retrospective Cohort Feasibility Study
The Ultrasound-guided Supra-inguinal Fascia Iliaca Block (SIFIB) is an advanced regional anesthesia technique strategically directed at the three primary nerves of the lumbar plexus. As the scope of regional anesthesia methods continues to grow in clinical application, this approach emerges as a versatile method. It can be used independently for pain management or as the primary anesthetic method, particularly in well-selected patients undergoing isolated limb surgeries or in combination with other regional anesthesia approaches.
Read the detailed description
The study follows a retrospective cohort feasibility design, conducted within the confines of a tertiary hospital. The requisite data for analysis was acquired by accessing patient records and electronic data systems. A cohort of 16 patients was carefully chosen for inclusion in the study, and the administration of blocks was carried out before the surgical procedures.
- Conditions
- Anesthesia, Anesthesia Management, Regional Anesthesia
- Being tested
- Suprainguinal fascia iliaca block
- Keywords
- Regional Anesthesia, Anesthesia Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprainguinal fascia iliaca blockOther
Also called Sciatic nerve block
The design of this study involved the retrospective analysis of data. Data was gathered from adult patients falling into the American Society of Anesthesiology (ASA) categories I to III, who were scheduled for elective lower limb surgical procedures. More specifically, patients who had undergone SIFIB either as the primary anesthesia approach or as part of their anesthesia regimen were included. Those who had received general anesthesia, neuraxial anesthesia, or infiltration anesthesia were excluded from the study. Importantly, all patients who participated in the study provided written informed consent for both their involvement in the study and the publication of their data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Block Success which provided surgical anesthesia, intraoperatively
After performing the blocks, the sensory block was examined with a pinprick test using a 27-gauge hypodermic needle, (0 = no sensory block; 1 = tactile sense present, no pain; 2 = no tactile sense and no pain). Cases with a score of 1 or 2 after 30 min were considered successful.
Measured: Intraoperatively and PACU unit (up to 2 hours)
Secondary outcomes (1)
Additional analgesic requirement
The number of patient who required intravenous ketamine or propofol infusion were recorded.
Measured: Intraoperatively and PACU unit (up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serkan Tulgar, M.D., Study director, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076096
- Sponsor's protocol ID
- SIFIB retrospective
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Supra-Inguinal Fascia Iliaca Block As an Anesthesia Method for Lower Extremity Surgeries: A Single-Center Retrospective Cohort Feasibility Study
- ClinicalTrials.gov ID
- NCT06076096
- Acronym / sponsor ID
- SIFIB retrospective
- Conditions
- Anesthesia, Anesthesia Management, Regional Anesthesia
- Keywords
- Regional Anesthesia, Anesthesia Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 10 Oct 2023 (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 Ultrasound-guided Supra-inguinal Fascia Iliaca Block (SIFIB) is an advanced regional anesthesia technique strategically directed at the three primary nerves of the lumbar plexus. As the scope of regional anesthesia methods continues to grow in clinical application, this approach emerges as a versatile method. It can be used independently for pain management or as the primary anesthetic method, particularly in well-selected patients undergoing isolated limb surgeries or in combination with other regional anesthesia approaches.
Detailed description
The study follows a retrospective cohort feasibility design, conducted within the confines of a tertiary hospital. The requisite data for analysis was acquired by accessing patient records and electronic data systems. A cohort of 16 patients was carefully chosen for inclusion in the study, and the administration of blocks was carried out before the surgical procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Specifically, we included patients who underwent SIFIB either as the primary anesthesia method or as a component of the anesthesia plan.
Key inclusion criteria (1 listed)
- ASA I-III patients who underwent elective lower limb surgical procedures.
Key exclusion criteria (1 listed)
- Patients who received general anesthesia, neuraxial anesthesia, or infiltration anesthesia were excluded.
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 |
|---|---|---|
| Suprainguinal fascia iliaca blockAlso: Sciatic nerve blockThe design of this study involved the retrospective analysis of data. Data was gathered from adult patients falling into the American Society of Anesthesiology (ASA) categories I to III, who were scheduled for elective lower limb surgical procedures. More specifically, patients who had undergone SIFIB either as the primary anesthesia approach or as part of their anesthesia regimen were included. Those who had received general anesthesia, neuraxial anesthesia, or infiltration anesthesia were excluded from the study. Importantly, all patients who participated in the study provided written informed consent for both their involvement in the study and the publication of their data. | Other | – |
Primary outcome
Block Success which provided surgical anesthesia, intraoperatively
Time frame: Intraoperatively and PACU unit (up to 2 hours)
After performing the blocks, the sensory block was examined with a pinprick test using a 27-gauge hypodermic needle, (0 = no sensory block; 1 = tactile sense present, no pain; 2 = no tactile sense and no pain). Cases with a score of 1 or 2 after 30 min were considered successful.
1 secondary outcome
Additional analgesic requirement
Time frame: Intraoperatively and PACU unit (up to 2 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 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Serkan Tulgar, M.D. study director
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Anesthesia Management, run by Samsun 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 1 inclusion and 1 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 10 Oct 2023. 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?
Block Success which provided surgical anesthesia, intraoperatively (time frame: Intraoperatively and PACU unit (up to 2 hours)). 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 10 Oct 2023; AzTrials last refreshed its copy on 2 Nov 2026.