Fascia Iliaca Compartmental BlockPhase 4NCT06745986
Ultrasound-Guided Fascia Iliaca Compartmental Block Versus Spinal Anesthesia in Femoral Thrombectomy
A Phase 4 study testing ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% ) and Spinal Anesthesia (bupivacaine) in people with Fascia Iliaca Compartmental Block and Femoral Thrombectomy, run by Port Said University hospital at 1 site in Egypt.
Trial summary
This study aims to assess the efficiency of Fascia Iliaca Compartmental Block in patients undergoing femoral thrombectomy versus spinal anesthesia. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Fascia Iliaca Compartmental Block, Femoral Thrombectomy, Spinal Anesthesia
- What is being tested?
- ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% ) and Spinal Anesthesia (bupivacaine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Dec 2017to 1 May 2021
- Phase
- Phase 4
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- scheduled femoral thrombectomy,
- both sexes,
- aged between 40-65 years,
- American Society of Anesthesiologists (ASA) II-III. Patients Criteria:
Who cannot join
- ASA status Grade IV, patient
- refused to participate,
- patients with contraindications to neuraxial anesthesia, such as systemic infection or history of allergy to anesthetic drugs
- infection at the site of injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Fascia Iliaca Compartmental Block Versus Spinal Anesthesia in Femoral Thrombectomy: A Randomized Double-Blind Study
This study aims to assess the efficiency of Fascia Iliaca Compartmental Block in patients undergoing femoral thrombectomy versus spinal anesthesia.
Read the detailed description
Anesthesia for lower limb revascularization consists of general anesthesia, neuraxial anesthesia and peripheral regional block. Fascia iliaca compartment block (FICB) is an anterior approach to the lumbar plexus and it blocks femoral nerve, LFCN, and limited numbers of nearby nerves such as ilioinguinal, genitor femoral.
- Being tested
- ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% ), Spinal Anesthesia (bupivacaine)
- Keywords
- Visual Analogue Score, UltraSound Guided, Fascia Iliaca Compartmental Block,, Spinal Anesthesia,, Femoral Thrombectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% )Drug
Fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml.
Spinal Anesthesia (bupivacaine)Drug
spinal anesthesia by 2.5 ml bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Fascia iliaca group | Active comparator | The ultrasound-guided fascia iliaca compartment block (FICB) group included 42 patients who had a fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml. Receives: Drug: ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% ) |
| spinal anesthesia | Active comparator | spinal anesthesia included 42 patients had spinal anesthesia with 2.5 ml bupivacaine 0.5%. Receives: Drug: Spinal Anesthesia (bupivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score postoperative
visual analogue score (VAS), with a scale from 0 to 10
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start13 Dec 2017
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fascia Iliaca Compartmental BlockStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eighty-four cases were scheduled for femoral thrombectomy and classified into tw0 equal groups (n=42 each), spinal group received spinal anesthesia with 0.5% hyperbaric bupivacaine in a total volume in a total volume 2.5ml and fascia iliaca group received ultrasound guided fascia iliaca block with 40ml of 0.25% bupivacaine for each block. Data collected for each block were onset and duration of sensory and motor block, visual analogue scale, analgesic duration and analgesic consumption, hemodynamics and complications.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Port Said University hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Ali Hassan, Port Said University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745986
- Sponsor's protocol ID
- MS/17.10.109
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Fascia Iliaca Compartmental Block Versus Spinal Anesthesia in Femoral Thrombectomy: A Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT06745986
- Acronym / sponsor ID
- MS/17.10.109
- Keywords
- Visual Analogue Score, UltraSound Guided, Fascia Iliaca Compartmental Block,, Spinal Anesthesia,, Femoral Thrombectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Port Said University hospitalUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 24 Dec 2024 (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.
This study aims to assess the efficiency of Fascia Iliaca Compartmental Block in patients undergoing femoral thrombectomy versus spinal anesthesia.
Detailed description
Anesthesia for lower limb revascularization consists of general anesthesia, neuraxial anesthesia and peripheral regional block. Fascia iliaca compartment block (FICB) is an anterior approach to the lumbar plexus and it blocks femoral nerve, LFCN, and limited numbers of nearby nerves such as ilioinguinal, genitor femoral.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eighty-four cases were scheduled for femoral thrombectomy and classified into tw0 equal groups (n=42 each), spinal group received spinal anesthesia with 0.5% hyperbaric bupivacaine in a total volume in a total volume 2.5ml and fascia iliaca group received ultrasound guided fascia iliaca block with 40ml of 0.25% bupivacaine for each block. Data collected for each block were onset and duration of sensory and motor block, visual analogue scale, analgesic duration and analgesic consumption, hemodynamics and complications.
| Arm | Type | Receives |
|---|---|---|
| Fascia iliaca group | Active comparator | Drug: ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% )The ultrasound-guided fascia iliaca compartment block (FICB) group included 42 patients who had a fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml. |
| spinal anesthesia | Active comparator | Drug: Spinal Anesthesia (bupivacaine)spinal anesthesia included 42 patients had spinal anesthesia with 2.5 ml bupivacaine 0.5%. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- scheduled femoral thrombectomy,
- both sexes,
- aged between 40-65 years,
- American Society of Anesthesiologists (ASA) II-III. Patients Criteria:
Key exclusion criteria (4 listed)
- ASA status Grade IV, patient
- refused to participate,
- patients with contraindications to neuraxial anesthesia, such as systemic infection or history of allergy to anesthetic drugs
- infection at the site of injection.
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 |
|---|---|---|
| ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% )Fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml. | Drug | Fascia iliaca group |
| Spinal Anesthesia (bupivacaine)spinal anesthesia by 2.5 ml bupivacaine 0.5% | Drug | spinal anesthesia |
Primary outcome
pain score postoperative
Time frame: 24 hours
visual analogue score (VAS), with a scale from 0 to 10
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 29 Jun 2026.
- Individual participant dataSharing planned: Yes
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 Phase 4 study testing ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% ) and Spinal Anesthesia (bupivacaine) in people with Fascia Iliaca Compartmental Block and Femoral Thrombectomy, run by Port Said University hospital 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 4 inclusion and 4 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 29 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
pain score postoperative (time frame: 24 hours). 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 29 Jun 2026.