SIFIB As an Anesthesia Method for Lower Extremity Surgeries

October 6, 2023 updated by: Samsun University

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Samsun, Turkey
        • Samsun University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Specifically, we included patients who underwent SIFIB either as the primary anesthesia method or as a component of the anesthesia plan.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperatively and PACU unit (up to 2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional analgesic requirement
Time Frame: Intraoperatively and PACU unit (up to 2 hours)
The number of patient who required intravenous ketamine or propofol infusion were recorded.
Intraoperatively and PACU unit (up to 2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SIFIB retrospective

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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