Ultrasound Guided Sciatic Nerve Block

NYU Langone Health

Status: Completed

Conditions: Sciatic Nerve

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02688439

14-01327

Details and patient eligibility

About

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

Enrollment: 81 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 3 patient groups

Leg in a neutral position

Active Comparator group

Description:

Sciatic nerve block, with leg kept in a neutral position after anesthesia (control group)

Treatment:

Other: Leg in a neutral position

Other: Sciatic Nerve block

Leg raised 30°

Experimental group

Description:

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

Treatment:

Other: Leg raised 30°

Other: Sciatic Nerve block

Distal tourniquet placed on the lower part of the leg

Experimental group

Description:

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.

Treatment:

Other: Leg in a neutral position

Other: Distal tourniquet placed on the lower part of the leg

Other: Sciatic Nerve block