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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04445480
Other study ID # SI198/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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