Chronic Lower Limb IschemiaNCT03798834
Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy
A study testing Fascia iliaca block (FIB) and Spinal anesthesia in people with Chronic Lower Limb Ischemia, run by Mansoura University at 1 site in Egypt.
Trial summary
The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and the lateral femoral cutaneous nerve. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Lower Limb Ischemia
- What is being tested?
- Fascia iliaca block (FIB) and Spinal anesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Nov 2018to 15 Apr 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I or II.
Who cannot join
- Patients with previous same lower limb surgery
- Neuromuscular disease
- Severe cardiovascular disease
- Any contraindications to regional anesthesia
- patient refusal
- coagulation abnormality
- Known allergy to local anesthetics
- Infection at the injection site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fascia Iliaca Block as an Anesthetic Technique for Thromboembolectomy of Chronic Lower Limb Ischemia
The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator, ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle but, rarely reaches the lumbar plexus.
The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of resistance technique. Feeling two tactile ''pops'' due to loss of resistance occurred during the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of FIB will increase the success rate and the efficacy of sensory blockade by decreasing the needed local anesthetic amount.
Read the detailed description
This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal. Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were secondary goals. The hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.
- Conditions
- Chronic Lower Limb Ischemia
- Being tested
- Fascia iliaca block (FIB), Spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia iliaca block (FIB)Drug
ultrasound-guided Fascia iliaca block
Spinal anesthesiaOther
Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Fascia iliaca block (FIB) | Experimental | ultrasound-guided Fascia iliaca block Receives: Drug: Fascia iliaca block (FIB) |
| Spinal anesthesia | Placebo comparator | Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5% Receives: Other: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of the patients who did not require conversion to general anesthesia
Measured: for 30 minutes
Secondary outcomes (6)
Postoperative pain
The post-operative pain will recorded using 10-point Visual Analog Scale (VAS)
Measured: For 24 hours after the intervention
Heart rate
changes in Heart rate
Measured: For 6 hours after the intervention
mean arterial pressure (MAP
changes in mean arterial pressure (MAP
Measured: For 6 hours after the intervention
hypotension
Incidents of hypotension
Measured: For 24 hours from the block
Any observed adverse effects
ny adverse effects will be observed over the 24 hours postoperative for local skin hematoma ,sensory deficits or local bleeding
Measured: over the 24 hours postoperative
bradycardia
Incidents if bradycardia
Measured: For 24 hours from the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start17 Nov 2018
- Primary completion1 Feb 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reem A Elsharkawy, MD, Study chair, Lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798834
- Sponsor's protocol ID
- R/17.07.111
- Status last verified
- Sep 2020
- First submitted
- 8 Jan 2019
- Last updated
- 22 Sep 2020
- 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 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Iliaca Block as an Anesthetic Technique for Thromboembolectomy of Chronic Lower Limb Ischemia
- ClinicalTrials.gov ID
- NCT03798834
- Acronym / sponsor ID
- R/17.07.111
- Conditions
- Chronic Lower Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 17 Nov 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 10 Jan 2019 (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.
The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator, ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle but, rarely reaches the lumbar plexus.
The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of resistance technique. Feeling two tactile ''pops'' due to loss of resistance occurred during the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of FIB will increase the success rate and the efficacy of sensory blockade by decreasing the needed local anesthetic amount.
Detailed description
This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal. Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were secondary goals. The hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia iliaca block (FIB) | Experimental | Drug: Fascia iliaca block (FIB)ultrasound-guided Fascia iliaca block |
| Spinal anesthesia | Placebo comparator | Other: Spinal anesthesiaSpinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5% |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I or II.
Key exclusion criteria (8 listed)
- Patients with previous same lower limb surgery
- Neuromuscular disease
- Severe cardiovascular disease
- Any contraindications to regional anesthesia
- patient refusal
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 |
|---|---|---|
| Fascia iliaca block (FIB)ultrasound-guided Fascia iliaca block | Drug | Fascia iliaca block (FIB) |
| Spinal anesthesiaSpinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5% | Other | Spinal anesthesia |
Primary outcome
The proportion of the patients who did not require conversion to general anesthesia
Time frame: for 30 minutes
6 secondary outcomes
Postoperative pain
Time frame: For 24 hours after the intervention
Heart rate
Time frame: For 6 hours after the intervention
mean arterial pressure (MAP
Time frame: For 6 hours after the intervention
hypotension
Time frame: For 24 hours from the block
Any observed adverse effects
Time frame: over the 24 hours postoperative
bradycardia
Time frame: For 24 hours from the block
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 22 Sep 2020.
- 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.
Reem A Elsharkawy, MD study chair
Lecturer of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia iliaca block (FIB) and Spinal anesthesia in people with Chronic Lower Limb Ischemia, run by Mansoura 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 1 inclusion and 8 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 22 Sep 2020. 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?
The proportion of the patients who did not require conversion to general anesthesia (time frame: for 30 minutes). 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 22 Sep 2020.