NCT06076096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

September 25, 2023

Last Update Submit

October 6, 2023

Conditions

Keywords

Regional AnesthesiaAnesthesia Management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Additional analgesic requirement

    Intraoperatively and PACU unit (up to 2 hours)

Interventions

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.

Also known as: Sciatic nerve block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, Turkey (Türkiye)

Location

Study Officials

  • Serkan Tulgar, M.D.

    Samsun University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 10, 2023

Study Start

March 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 15, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations