Ultrasound Guided Sciatic Nerve Block

Not Applicable

Completed

• Conditions: Sciatic Nerve
• Interventions: Other: Sciatic Nerve block; Other: Leg in a neutral position; Other: Leg raised 30°; Other: Distal tourniquet placed on the lower part of the leg

• Registration Number: NCT02688439
• Lead Sponsor: NYU Langone Health

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Primary Completion: 2017-12-29
• Study Completion: 2019-07-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leg in a neutral position	Leg in a neutral position	Sciatic nerve block, with leg kept in a neutral position after anesthesia (control group)
Distal tourniquet placed on the lower part of the leg	Sciatic Nerve block	Sciatic nerve block, 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.
Distal tourniquet placed on the lower part of the leg	Leg in a neutral position	Sciatic nerve block, 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.
Leg in a neutral position	Sciatic Nerve block	Sciatic nerve block, with leg kept in a neutral position after anesthesia (control group)
Leg raised 30°	Sciatic Nerve block	Sciatic nerve block, 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
Leg raised 30°	Leg raised 30°	Sciatic nerve block, 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
Distal tourniquet placed on the lower part of the leg	Distal tourniquet placed on the lower part of the leg	Sciatic nerve block, 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.

Primary Outcome Measures

Name	Time	Method
Evaluation of motor block evaluated by measuring movement on the scale of 0 to 5 as compared to the other foot.	15 Minutes
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.	15 Minutes
Level of pain measured on a scale of 0 to 10 (0 being no pain; 10 being most pain) prior to first pain killer	15 Minutes

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States