SIFIB As an Anesthesia Method for Lower Extremity Surgeries

• Sponsor: Samsun University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06076096
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Actual Duration (Months): 12.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Anesthesia Management; Regional Anesthesia	Other: Suprainguinal fascia iliaca block

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

• Study Type: Observational
• Actual Enrollment: 16 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Ultrasound-Guided Supra-Inguinal Fascia Iliaca Block As an Anesthesia Method for Lower Extremity Surgeries: A Single-Center Retrospective Cohort Feasibility Study
• Actual Study Start Date: Mar 1, 2022
• Actual Primary Completion Date: Mar 1, 2023
• Actual Study Completion Date: Mar 15, 2023

Outcome Measures

Primary Outcome Measures

1. Block Success which provided surgical anesthesia, intraoperatively [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.

Secondary Outcome Measures

1. Additional analgesic requirement [Intraoperatively and PACU unit (up to 2 hours)]

   The number of patient who required intravenous ketamine or propofol infusion were recorded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsun University	Samsun		Turkey

Sponsors and Collaborators

• Samsun University

Investigators

• Study Director: Serkan Tulgar, M.D., Samsun University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsun University
• ClinicalTrials.gov Identifier: NCT06076096
• Other Study ID Numbers: SIFIB retrospective
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Samsun University: Regional Anesthesia; Anesthesia Management

Study Results

No Results Posted as of Oct 10, 2023