Ultrasound Guided Sciatic Nerve Block

NCT ID: NCT02688439

Last Updated: 2019-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-07-10

Brief Summary

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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

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Conditions

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Sciatic Nerve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Leg in a neutral position

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

Group Type ACTIVE_COMPARATOR

Sciatic Nerve block

Intervention Type OTHER

Leg in a neutral position

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Sciatic Nerve block

Intervention Type OTHER

Leg raised 30°

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Sciatic Nerve block

Intervention Type OTHER

Distal tourniquet placed on the lower part of the leg

Intervention Type OTHER

Leg in a neutral position

Intervention Type OTHER

Interventions

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Sciatic Nerve block

Intervention Type OTHER

Leg raised 30°

Intervention Type OTHER

Distal tourniquet placed on the lower part of the leg

Intervention Type OTHER

Leg in a neutral position

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Levon Capan, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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14-01327

Identifier Type: -

Identifier Source: org_study_id

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