SIFIB As an Anesthesia Method for Lower Extremity Surgeries

Anesthesia Clinical Trial

Official title:

Ultrasound-Guided Supra-Inguinal Fascia Iliaca Block As an Anesthesia Method for Lower Extremity Surgeries: A Single-Center Retrospective Cohort Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06076096
• Other study ID #: SIFIB retrospective
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: October 2023
• Source: Samsun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 15, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• ASA I-III patients who underwent elective lower limb surgical procedures.

Exclusion Criteria:

• Patients who received general anesthesia, neuraxial anesthesia, or infiltration anesthesia were excluded.

Related Conditions & MeSH terms

• Anesthesia
• Regional Anesthesia

Intervention

Other:
• Suprainguinal fascia iliaca 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.

Locations

Country	Name	City	State
Turkey	Samsun University	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intraoperatively and PACU unit (up to 2 hours)
Secondary	Additional analgesic requirement	The number of patient who required intravenous ketamine or propofol infusion were recorded.	Intraoperatively and PACU unit (up to 2 hours)