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Completed

NCT Number: NCT02688439

Ultrasound Guided Sciatic Nerve Block

The primary purpose of this study is to determine whether the leg positioning or distal tourniquet used during the injection of local anesthetic may decrease the onset time and prolong the duration of analgesia of ultrasound-guided Sciatic Nerve Block (SNB) with popliteal approach. Patients will be divided randomly into three groups: group 1 will receive sciatic nerve block, with leg kept in a neutral position after anesthesia (control group); group 2 will receive the same anesthesia, with leg raised 30° by placing the back of the foot over a support placed on the OR table and maintained in that position for 15 min; and patients in group 3 will receive the same anesthesia, and distal tourniquet placed on the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle) with the leg in a neutral position

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Key information

Conditions

Sciatic Nerve

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing elective foot surgery under ultrasound guided popliteal sciatic/saphenous block
  • American Society of Anesthesiologist physical status 1-3, meaning patients who are either completely or their systemic disease(s), if they have is (are) under control with medications or other means.
  • Have capacity to provide informed consent.

Exclusion criteria

  • clinically significant coagulopathy (impaired blood clotting)
  • infection at injection site
  • allergy to local anesthetics
  • severe cardiopulmonary disease (heart and lung disease)
  • body mass index >35 kg.m2
  • known neuropathies (degenerative, infectious and traumatic peripheral nerve diseases)
  • who are receiving opioids for chronic analgesic therapy at the time of contemplated surgery
  • Patients with history of AIDS, tuberculosis, and other infections
  • active and/or unstable cardiac, renal, pulmonary and neurologic disorders will be excluded from the study. This includes patients in heart failure having limited exercise ability, end stage renal failure on dialysis treatment, recent stroke etc.
  • Vulnerable subjects (children, pregnant subjects, prisoners, mentally impaired) also will not be included in the study.
  • Subjects who do not understand or speak English

Treatment and study plan

Sciatic Nerve block

Other

Leg raised 30°

Other

Distal tourniquet placed on the lower part of the leg

Other

Leg in a neutral position

Other

Primary outcomes

  1. Evaluation of Sensory block by measuring decrease in sensation on the scale of 0 to 5 (0 being no sensation; 5 being most sensation) as compared to the other foot.

    Time frame: 15 Minutes

  2. Evaluation of motor block evaluated by measuring movement on the scale of 0 to 5 as compared to the other foot.

    Time frame: 15 Minutes

  3. Level of pain measured on a scale of 0 to 10 (0 being no pain; 10 being most pain) prior to first pain killer

    Time frame: 15 Minutes

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Effect of Leg Positioning and Tourniquet Inflation on Onset and Duration of Ultrasound Guided Sciatic Nerve Block After Injection of Local Anesthetic

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Feb 23, 2016
Registry last updated
Aug 5, 2019

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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