NCT06913348

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 1, 2025

Last Update Submit

March 29, 2025

Conditions

Keywords

popliteal nerve blockESPB

Outcome Measures

Primary Outcomes (1)

  • Block quality

    Assessment of the occurrence of complete motor and sensory block.

    Baseline (immediately after block administration).

Secondary Outcomes (1)

  • Postoperative Analgesia Duration

    Up to 24 hours postoperatively.

Study Arms (2)

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

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 GroupUltrasound-Guided Sciatic Popliteal Nerve Block Group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Both sexes and from 20 to 80 years

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia university hospital

Minya, Minia Governorate, 61519, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

comparison of popliteal sciatic nerve block versus ESPB .

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Amr Nady Abd Elrazik, assistant professor

    Minia University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ultrasound guided sciatic popliteal nerve block versus Erector spinae plane block in patients undergoing endovascular management of critical lower limb ischemia.

Study Record Dates

First Submitted

March 1, 2025

First Posted

April 6, 2025

Study Start

March 20, 2024

Primary Completion

October 20, 2024

Study Completion

January 5, 2025

Last Updated

April 6, 2025

Record last verified: 2025-03

Locations