Critical Limb Ischemia (CLI)NCT06913348
Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erector Spinae Plane Block in Endovascular Management of CLI
An observational study of Critical Limb Ischemia (CLI) and Popliteal Nerve Block, run by Minia University Hospital at 1 site in Egypt.
Trial summary
Comparison of popliteal sciatic nerve block and erector spinae plane block (ESPB) in patients undergoing endovascular management of critical lower limb ischemia (CLI). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Critical Limb Ischemia (CLI), Popliteal Nerve Block, ESPB
- What is being tested?
- Popliteal sciatic nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2024to 5 Jan 2025
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both sexes and from 20 to 80 years
Who may be able to join
- Patient age will be 20-70 years.
- Patients will be diagnosed with critical lower limb ischemia by clinical presentations and investigations.
- ASA physical status 2-3
Who cannot join
- Patient refusal to participate in this study.
- Patient inability to understand the scales or to describe to the investigators.
- Coagulation disorder.
- Sever renal or kidney dysfunction.
- Taking opioids before admission.
- Morbid obesity .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erector Spinae Plane Block in Patients Undergoing Endovascular Management of Critical Lower Limb Ischemia
Comparison of popliteal sciatic nerve block and erector spinae plane block (ESPB) in patients undergoing endovascular management of critical lower limb ischemia (CLI).
Read the detailed description
Nerve blocks, particularly regional anesthesia techniques, have been increasingly used in the endovascular management of critical lower limb ischemia (CLI). These techniques offer numerous advantages over general and local anesthesia.
Primary Advantages of Nerve Blocks:
- Superior Pain Control Nerve blocks, such as femoral and sciatic nerve blocks, provide effective pain relief by anesthetizing the nerve supply to the lower limb. They offer more comprehensive analgesia than local anesthesia alone, as they numb the entire area around the puncture site.
- Enhanced Patient Comfort Nerve blocks allow patients to remain pain-free during and after the procedure. They minimize discomfort even in lengthy or complex cases.
- Reduction in Systemic Analgesic Requirements By providing localized anesthesia, nerve blocks significantly reduce the need for systemic analgesics, particularly opioids. This is essential because CLI patients often have comorbidities that make opioid use risky.
- Fewer Opioid-Related Side Effects Nerve blocks reduce the incidence of opioid-related side effects, including nausea, vomiting, respiratory depression, and sedation.
- Improved Hemodynamic Stability
Nerve blocks preserve autonomic nervous system function, reducing fluctuations in blood pressure and heart rate compared to general anesthesia.
This is especially beneficial for CLI patients, who frequently have underlying cardiovascular disease.
- Conditions
- Critical Limb Ischemia (CLI), Popliteal Nerve Block, ESPB
- Being tested
- Popliteal sciatic nerve block
- Keywords
- popliteal nerve block, ESPB
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Popliteal sciatic nerve blockProcedure or surgery
Procedure/Surgery: Patients will receive either an ultrasound-guided sciatic popliteal nerve block or an ultrasound-guided erector spinae plane block for anesthesia during endovascular management of critical lower limb ischemia.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Sciatic Popliteal Nerve Block Group | Patients in this group will receive an ultrasound-guided sciatic popliteal nerve block for anesthesia during endovascular management of critical lower limb ischemia. Receives: Procedure: Popliteal sciatic nerve block | |
| Erector Spinae Plane Block Group | Patients in this group will receive an ultrasound-guided erector spinae plane block for anesthesia during endovascular management of critical lower limb ischemia. Receives: Procedure: Popliteal sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block quality
Assessment of the occurrence of complete motor and sensory block.
Measured: Baseline (immediately after block administration).
Secondary outcomes (1)
Postoperative Analgesia Duration
Time from block administration to the first request for rescue analgesia.
.
Measured: Up to 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2024
- Primary completion20 Oct 2024
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb Ischemia (CLI)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed hassan ahmed, Minia University Hospital
- Investigators
- Amr Nady Abd Elrazik, assistant professor, Study director, Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913348
- Sponsor's protocol ID
- ID number (1226/07/2024)
- Status last verified
- Mar 2025
- First submitted
- 1 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erector Spinae Plane Block in Patients Undergoing Endovascular Management of Critical Lower Limb Ischemia
- ClinicalTrials.gov ID
- NCT06913348
- Acronym / sponsor ID
- ID number (1226/07/2024)
- Conditions
- Critical Limb Ischemia (CLI), Popliteal Nerve Block, ESPB
- Keywords
- popliteal nerve block, ESPB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Minia University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 6 Apr 2025 (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.
Comparison of popliteal sciatic nerve block and erector spinae plane block (ESPB) in patients undergoing endovascular management of critical lower limb ischemia (CLI).
Detailed description
Nerve blocks, particularly regional anesthesia techniques, have been increasingly used in the endovascular management of critical lower limb ischemia (CLI). These techniques offer numerous advantages over general and local anesthesia.
Primary Advantages of Nerve Blocks:
- Superior Pain Control Nerve blocks, such as femoral and sciatic nerve blocks, provide effective pain relief by anesthetizing the nerve supply to the lower limb. They offer more comprehensive analgesia than local anesthesia alone, as they numb the entire area around the puncture site.
- Enhanced Patient Comfort Nerve blocks allow patients to remain pain-free during and after the procedure. They minimize discomfort even in lengthy or complex cases.
- Reduction in Systemic Analgesic Requirements By providing localized anesthesia, nerve blocks significantly reduce the need for systemic analgesics, particularly opioids. This is essential because CLI patients often have comorbidities that make opioid use risky.
- Fewer Opioid-Related Side Effects Nerve blocks reduce the incidence of opioid-related side effects, including nausea, vomiting, respiratory depression, and sedation.
- Improved Hemodynamic Stability
Nerve blocks preserve autonomic nervous system function, reducing fluctuations in blood pressure and heart rate compared to general anesthesia.
This is especially beneficial for CLI patients, who frequently have underlying cardiovascular disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Sciatic Popliteal Nerve Block Group | – | Procedure: Popliteal sciatic nerve blockPatients in this group will receive an ultrasound-guided sciatic popliteal nerve block for anesthesia during endovascular management of critical lower limb ischemia. |
| Erector Spinae Plane Block Group | – | Procedure: Popliteal sciatic nerve blockPatients in this group will receive an ultrasound-guided erector spinae plane block for anesthesia during endovascular management of critical lower limb ischemia. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both sexes and from 20 to 80 years
Key inclusion criteria (3 listed)
- Patient age will be 20-70 years.
- Patients will be diagnosed with critical lower limb ischemia by clinical presentations and investigations.
- ASA physical status 2-3
Key exclusion criteria (6 listed)
- Patient refusal to participate in this study.
- Patient inability to understand the scales or to describe to the investigators.
- Coagulation disorder.
- Sever renal or kidney dysfunction.
- Taking opioids before admission.
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 |
|---|---|---|
| Popliteal sciatic nerve blockProcedure/Surgery: Patients will receive either an ultrasound-guided sciatic popliteal nerve block or an ultrasound-guided erector spinae plane block for anesthesia during endovascular management of critical lower limb ischemia. | Procedure or surgery | Erector Spinae Plane Block Group, Ultrasound-Guided Sciatic Popliteal Nerve Block Group |
Primary outcome
Block quality
Time frame: Baseline (immediately after block administration).
Assessment of the occurrence of complete motor and sensory block.
1 secondary outcome
Postoperative Analgesia Duration
Time frame: Up to 24 hours postoperatively.
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 6 Apr 2025.
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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.
Amr Nady Abd Elrazik, assistant professor study director
Minia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia (CLI) and Popliteal Nerve Block, run by Minia 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 3 inclusion and 6 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 6 Apr 2025. 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?
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?
Block quality (time frame: Baseline (immediately after block administration).). 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 6 Apr 2025.