Low Ejection Fraction PatientsNCT05506501
Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction
A study testing unilateral epidural anesthesia and Ultrasound guided femoro/ sciatic nerve block in people with Low Ejection Fraction Patients and Fracture Tibia, run by Ain Shams University at 1 site in Egypt.
Trial summary
compare unilateral epidural anesthesia versus femoral/sciatic nerve block by ultrasound guided as anesthetic technique for cases with low ejection fraction undergoing insertion of nail tibia for fixation of fracture shaft tibia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Ejection Fraction Patients, Fracture Tibia
- What is being tested?
- unilateral epidural anesthesia and Ultrasound guided femoro/ sciatic nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Jan 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years old.
- Patients scheduled for elective insertion of nail tibia for fixation of fracture shaft tibia.
- Patients with low ejection fraction (30-40%).
Who cannot join
- Patient refusal
- Uncooperative patient
- Unconscious patients
- Cases with head trauma
- History of relevant drug allergy to local anesthetics
- Local infection at the site of the block
Show all 9Show fewer
- Patients with coagulopathies and impaired platelet functions
- Patients with hemodynamic instability
- Previous neurological deficit in lower limb and previous femoral artery grafts or injuries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Intentional Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction Undergoing Insertion of Nail Tibia for Fixation of Fracture Shaft Tibia
compare unilateral epidural anesthesia versus femoral/sciatic nerve block by ultrasound guided as anesthetic technique for cases with low ejection fraction undergoing insertion of nail tibia for fixation of fracture shaft tibia.
Read the detailed description
Group A ;( Unilateral epidural anesthesia group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia.
Group B;;( Ultrasound guided femoro/ sciatic nerve block group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance.
For each patient, onset of sensory and motor block, degree of motor block, sign of sensory block in the contralateral lower limb for the epidural group, success in providing adequate anesthesia, hemodynamic changes, time of first analgesic request will be recorded.
- Conditions
- Low Ejection Fraction Patients, Fracture Tibia
- Being tested
- unilateral epidural anesthesia, Ultrasound guided femoro/ sciatic nerve block
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral epidural anesthesiaProcedure or surgery
Also called Ultrasound guided femoro/ sciatic nerve block
Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia.
Ultrasound guided femoro/ sciatic nerve blockProcedure or surgery
Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral epidural anesthesia group | Active comparator | Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia. Receives: Procedure: unilateral epidural anesthesia |
| Ultrasound guided femoro/ sciatic nerve block group | Active comparator | Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance. Receives: Procedure: Ultrasound guided femoro/ sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean blood pressure
Measured: 20 minutes after anesthesia
Secondary outcomes (3)
adequate sensory block
Measured: 20 minutes after the block
adequate motor block
Measured: 15 minutes after the block
time of first analgesic request
Measured: within 24 hours after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Ejection Fraction PatientsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506501
- Sponsor's protocol ID
- OFT IRB00006379
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intentional Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction Undergoing Insertion of Nail Tibia for Fixation of Fracture Shaft Tibia
- ClinicalTrials.gov ID
- NCT05506501
- Acronym / sponsor ID
- OFT IRB00006379
- Conditions
- Low Ejection Fraction Patients, Fracture Tibia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 18 Aug 2022 (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.
compare unilateral epidural anesthesia versus femoral/sciatic nerve block by ultrasound guided as anesthetic technique for cases with low ejection fraction undergoing insertion of nail tibia for fixation of fracture shaft tibia.
Detailed description
Group A ;( Unilateral epidural anesthesia group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia.
Group B;;( Ultrasound guided femoro/ sciatic nerve block group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance.
For each patient, onset of sensory and motor block, degree of motor block, sign of sensory block in the contralateral lower limb for the epidural group, success in providing adequate anesthesia, hemodynamic changes, time of first analgesic request will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral epidural anesthesia group | Active comparator | Procedure: unilateral epidural anesthesiaForty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia. |
| Ultrasound guided femoro/ sciatic nerve block group | Active comparator | Procedure: Ultrasound guided femoro/ sciatic nerve blockForty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 60 years old.
- Patients scheduled for elective insertion of nail tibia for fixation of fracture shaft tibia.
- Patients with low ejection fraction (30-40%).
Key exclusion criteria (9 listed)
- Patient refusal
- Uncooperative patient
- Unconscious patients
- Cases with head trauma
- History of relevant drug allergy to local anesthetics
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 |
|---|---|---|
| unilateral epidural anesthesiaAlso: Ultrasound guided femoro/ sciatic nerve blockForty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia. | Procedure or surgery | Unilateral epidural anesthesia group |
| Ultrasound guided femoro/ sciatic nerve blockForty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance. | Procedure or surgery | Ultrasound guided femoro/ sciatic nerve block group |
Primary outcome
mean blood pressure
Time frame: 20 minutes after anesthesia
3 secondary outcomes
adequate sensory block
Time frame: 20 minutes after the block
adequate motor block
Time frame: 15 minutes after the block
time of first analgesic request
Time frame: within 24 hours after the block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: Yes
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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 unilateral epidural anesthesia and Ultrasound guided femoro/ sciatic nerve block in people with Low Ejection Fraction Patients and Fracture Tibia, run by Ain Shams 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Aug 2022. 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.
Are results available for this study?
Results are not available in the source record.
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?
mean blood pressure (time frame: 20 minutes after anesthesia). 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 Aug 2022.