- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06076096
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
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.
Clinical Trials on Anesthesia
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Aligarh Muslim UniversityCompletedAnesthesia | Anesthesia Intubation Complication | Anesthesia; Adverse EffectIndia
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
University Health Network, TorontoActive, not recruiting
-
University of PecsCompleted
-
Hormozgan University of Medical SciencesUnknownAnesthesia | Anesthesia; FunctionalIran, Islamic Republic of
-
Ankara City Hospital BilkentCompletedAnesthesia | Sedation | Anesthesia, Intravenous | Sedation Complication | Recovery From Anesthesia | Monitoring of Depth of AnesthesiaTurkey (Türkiye)
-
Children's Hospital Los AngelesNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingAnesthesia | Anesthesia; ReactionUnited States
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMRecruiting
Clinical Trials on Suprainguinal fascia iliaca block
-
Sivas Numune HospitalRecruitingPostoperative Pain | Acute Postoperative Pain | Hip Arthroplasty | Regional AnesthesiaTurkey (Türkiye)
-
University College Hospital GalwayRecruitingTotal Hip Arthroplasty (THA)Ireland
-
Hitit UniversityRecruitingPost Operative PainTurkey (Türkiye)
-
Cumhuriyet UniversityNot yet recruiting
-
Ain Shams UniversityCompleted
-
Kocaeli City HospitalCompletedPain, Postoperative | Knee Arthroplasty, Total | Peripheral Nerve BlockTurkey
-
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training...RecruitingPostoperative Pain | Hip Fracture | Regional AnesthesiaTurkey (Türkiye)
-
SSM Health Bone and Joint Hospital at St AnthonyRecruitingAnalgesiaUnited States
-
Al-Azhar UniversityBenha UniversityCompletedHip Fractures | Spinal AnesthesiaEgypt
-
Udayana UniversityEnrolling by invitationPain, PostoperativeIndonesia