- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07594366
Suprainguinal Facia Iliaca Block in Maximizing the Feasibility of Positioning for Spinal Anesthesia
Effectiveness of Suprainguinal Facia Iliaca Block in Maximizing the Feasibility of Positioning for Spinal Anesthesia in Patients With Hip and Proximal Femur Fractures, a Placebo Randomized Controlled Study
In this study, we assessed the effect of suprainguinal facia iliaca block in maximizing the feasibility of positioning for spinal anaesthesia in patients with hip and proximal femur fractures by determining the angle that could be achieved and success rate of spinal anesthesia The control group received a sham block with the same technique of suprainguinal fascia iliaca block before being given spinal anaesthesia.
The interventional group received suprainguinal fascia iliaca block before being given spinal anaesthesia.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ismailia, Egypt
- Faculty of Medicine, Suez Canal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients are ASA I (American Society of Anesthesiologists physical status grade I) = normal healthy patients, ASA II (American Society of Anesthesiologists physical status grade II) = patients with mild systemic disease and no functional limitations, or ASA III (American Society of Anesthesiologists physical status grade III) = patients with moderate systemic disease and some functional limitations.
- Patients having hip and/or proximal femur fractures.
Exclusion Criteria:
- Patient refusal to participate in the study
- Patients' refusal for regional anaesthesia
- Patients have other combined fractures rather than unilateral hip or proximal femur fractures.
- Underlying coagulopathies.
- Local infection.
- Known allergy to LA.
- Body mass index (BMI) more than 40 kg/m².
- Heart block greater than first-degree.
- Renal and hepatic dysfunction.
- Neurological diseases such as Alzheimer's and dementia or apparent psychological instability.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Fascia iliaca compartment block
Fascia iliaca block was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml of 0.5% bupivacaine.
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Fascia iliaca compartment block (FICB) was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml of 0.5% bupivacaine.
|
|
Sham Comparator: Sham group
Sham block was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml normal saline.
|
Sham block was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml normal saline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of Fowler's position
Time Frame: 30 minutes after the fascia iliaca compartment block or sham block and till the full sitting position before spinal anaesthesia.
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Measure and compare the maximum tolerable degree of Fowler's position after fascia iliaca compartment block (FICB) and sham block in order to give spinal anaesthesia.
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30 minutes after the fascia iliaca compartment block or sham block and till the full sitting position before spinal anaesthesia.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fascia Iliaca
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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