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Clinical Trials/NCT04445480
NCT04445480
Completed
Not Applicable

The Benefit of Popliteal Sciatic Nerve Block for Lower Limb Angioplasty in Critical Limb Ischemia: a Randomised Controlled Trial

Mahidol University1 site in 1 country40 target enrollmentMay 7, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Angioplasty
Sponsor
Mahidol University
Enrollment
40
Locations
1
Primary Endpoint
Incidence of general anaesthesia
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Endovascular revascularization is an effective procedure in treatment of chronic critical limb ischemia. The less invasive procedure in high risk patients produce the benefit to the patients. However, some of the patients cannot tolerate local anaesthesia. These patients need sedation or even general anaesthesia, which increase unnecessary risk to the patients. This study is conducted to evaluate the benefit of popliteal sciatic nerve block or popliteal block compare to sedation in critical limb patients undergoing angioplasty.

Registry
clinicaltrials.gov
Start Date
May 7, 2019
End Date
March 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age more than 20 year-old with chronic ischemic limb pain
  • Scheduled for peripheral angioplasty under monitor anaesthesia care
  • Expected timing of procedure not more than 3 hours

Exclusion Criteria

  • Age less than 21
  • Cannot cooperate with the staff
  • Having pain in other areas or both legs
  • Contraindicate for nerve block
  • Allergy to local anesthetic drugs or sedative drugs

Outcomes

Primary Outcomes

Incidence of general anaesthesia

Time Frame: Five hours

Secondary Outcomes

  • Numerical pain rating scale during procedure(Five hours)

Study Sites (1)

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