Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erect... | NCT06913348

Studies
Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erector Spinae Plane Block in Endovascular Management of CLI

NCT06913348

Sponsor

Minia University Hospital

Status

Completed

Last Update Posted

Apr 6, 2025Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Critical Limb Ischemia (CLI)
Popliteal Nerve Block
ESPB

Interventions

Popliteal sciatic nerve block

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2024Actual

Primary Completion Date

Oct 20, 2024Actual

Completion Date

Jan 5, 2025Actual

First Submitted Date

Mar 1, 2025

First Submission Date that Met QC Criteria

Mar 29, 2025

First Posted Date

Apr 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2025

Last Update Posted Date

Apr 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed hassan ahmed, Ultrasound guided sciatic popliteal nerve block versus Erector spinae plane block in patients undergoing endovascular management of critical lower limb ischemia., Minia University HospitalPrincipal Investigator

Lead Sponsor

Minia University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Procedure: Popliteal sciatic nerve block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Popliteal sciatic nerve block	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Block quality	Assessment of the occurrence of complete motor and sensory block.	Baseline (immediately after block administration).

Secondary Outcomes

Measure	Description	Time Frame
Postoperative Analgesia Duration	Time from block administration to the first request for rescue analgesia. .	Up to 24 hours postoperatively.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 .

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Both sexes and from 20 to 80 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amr Nady Abd Elrazik, assistant professor	Minia University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minia university hospital		Minya	Minia Governorate	61519	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000089802	Chronic Limb-Threatening Ischemia

Ancestor Terms

ID	Term
D058729	Peripheral Arterial Disease
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

Browse Leaves

Not provided

Browse Branches

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