Popliteal Block for Lower Limb Angioplasty

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT04445480

Collaborator

(none)

Enrollment

Location

Arms

9.8

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Angioplasty Anaesthesia and Analgesia	Procedure: Popliteal block Other: Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 7, 2019

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Popliteal block group	Procedure: Popliteal block Sciatic nerve block at popliteal fossa would perform before the participant undergoing angioplasty in experimental arm.
Active Comparator: Control group	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.

Arm

Intervention/Treatment

Experimental: Popliteal block group

Procedure: Popliteal block

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

Active Comparator: Control group

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.

Outcome Measures

Primary Outcome Measures

Incidence of general anaesthesia [Five hours]

Secondary Outcome Measures

Numerical pain rating scale during procedure [Five hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anesthesiology department, Siriraj Hospital, Mahidol University	Bangkok		Thailand

Sponsors and Collaborators

Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahidol University

ClinicalTrials.gov Identifier:

NCT04445480

Other Study ID Numbers:

SI198/2019

First Posted:

Jun 24, 2020

Last Update Posted:

Jun 24, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mahidol University

popliteal block

chronic limb ischemia

Study Results

No Results Posted as of Jun 24, 2020