Popliteal Block for Lower Limb Angioplasty

Not Applicable

Completed

• Conditions: Angioplasty; Anaesthesia and Analgesia
• Interventions: Procedure: Popliteal block; Other: Control

• Registration Number: NCT04445480
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-07
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Study First Submitted: 2020-03-04
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-22
• Last Update Submitted: 2020-06-22
• Study First Posted: 2020-06-24
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Popliteal block group	Popliteal block	-
Control group	Control	-

Primary Outcome Measures

Name	Time	Method
Incidence of general anaesthesia	Five hours

Secondary Outcome Measures

Name	Time	Method
Numerical pain rating scale during procedure	Five hours

Trial Locations

Locations (1)

Anesthesiology department, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand