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

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).

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia (CLI); ESPB; Popliteal Nerve Block
• Intervention / Treatment: Procedure: Popliteal sciatic nerve block

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:

1. 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.

2. 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.

3. 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.

4. Fewer Opioid-Related Side Effects

   Nerve blocks reduce the incidence of opioid-related side effects, including nausea, vomiting, respiratory depression, and sedation.

5. 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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Egypt
  • Minia governorate
    • Minia, Minia governorate, Egypt, 61519
      • Minia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Both sexes and from 20 to 80 years

Description

Inclusion Criteria:

1. Patient age will be 20-70 years.
2. Patients will be diagnosed with critical lower limb ischemia by clinical presentations and investigations.
3. ASA physical status 2-3

Exclusion Criteria:

1. Patient refusal to participate in this study.
2. Patient inability to understand the scales or to describe to the investigators.
3. Coagulation disorder.
4. Sever renal or kidney dysfunction.
5. Taking opioids before admission.
6. Morbid obesity .

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Minia University Hospital
• Investigators: Study Director: Amr Nady Abd Elrazik, assistant professor, Minia University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): October 20, 2024
• Study Completion (Actual): January 5, 2025

Study Registration Dates

• First Submitted: March 1, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: popliteal nerve block; ESPB
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Ischemia
• Other Study ID Numbers: ID number (1226/07/2024)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No