Spinal Anaesthetic PoisoningNCT07594366
Suprainguinal Facia Iliaca Block in Maximizing the Feasibility of Positioning for Spinal Anesthesia
A study testing Bubpivacaine and Normal Saline in people with Spinal Anaesthetic Poisoning and Spinal Anaesthesia, run by Suez Canal University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Anaesthetic Poisoning, Spinal Anaesthesia
- What is being tested?
- Bubpivacaine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spinal Anaesthetic Poisoning, Spinal Anaesthesia
- Being tested
- Bubpivacaine, Normal Saline
- Keywords
- spinal anaesthesia positioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BubpivacaineDrug
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.
Normal SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fascia iliaca compartment block | Active comparator | 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. Receives: Drug: Bubpivacaine |
| Sham group | Sham comparator | 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Fowler's position
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.
Measured: 30 minutes after the fascia iliaca compartment block or sham block and till the full sitting position before spinal anaesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Sep 2022
- Primary completion30 Nov 2024
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anaesthetic PoisoningStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group 1 - Fascia iliaca block with bupivacaine 0.5% was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room. * Group 2 - 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. Each group included 20 patients. Fascia iliaca block was performed while patients were in the supine position with all aseptic precautions.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594366
- Sponsor's protocol ID
- Fascia Iliaca
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07594366
- Acronym / sponsor ID
- Fascia Iliaca
- Conditions
- Spinal Anaesthetic Poisoning, Spinal Anaesthesia
- Keywords
- spinal anaesthesia positioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- * Group 1 - Fascia iliaca block with bupivacaine 0.5% was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room. * Group 2 - 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. Each group included 20 patients. Fascia iliaca block was performed while patients were in the supine position with all aseptic precautions.
| Arm | Type | Receives |
|---|---|---|
| Fascia iliaca compartment block | Active comparator | Drug: BubpivacaineFascia 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. |
| Sham group | Sham comparator | Drug: Normal SalineSham block was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml normal saline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BubpivacaineFascia 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. | Drug | Fascia iliaca compartment block |
| Normal SalineSham block was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml normal saline. | Drug | Sham group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bubpivacaine and Normal Saline in people with Spinal Anaesthetic Poisoning and Spinal Anaesthesia, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.