Popliteal Block for Lower Limb Angioplasty

Angioplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445480
• Other study ID #: SI198/2019
• Status: Completed
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: June 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaesthesia and Analgesia
• Angioplasty

Intervention

Procedure:
• Popliteal block
Sciatic nerve block at popliteal fossa would perform before the participant undergoing angioplasty in experimental arm.

Other:
• Control
Sciatic nerve at popliteal fossa would be scanned with the ultrasound. The toothpick would be applied to simulate the procedure of nerve block.

Locations

Country	Name	City	State
Thailand	Anesthesiology department, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of general anaesthesia		Five hours
Secondary	Numerical pain rating scale during procedure		Five hours