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OpenTrials
Completed

NCT Number: NCT04445480

Popliteal Block for Lower Limb Angioplasty

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.

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Key information

Conditions

Angioplasty Agnosia Anaesthesia and Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesiology department, Siriraj Hospital, Mahidol University

Bangkok, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Popliteal block

Procedure

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

Control

Other

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

Primary outcomes

  1. Incidence of general anaesthesia

    Time frame: Five hours

Secondary outcomes

  1. Numerical pain rating scale during procedure

    Time frame: Five hours

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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