Ultrasound Guided Sciatic Nerve Block

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

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

Study Overview

• Status: Completed
• Conditions: Sciatic Nerve
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Leg in a neutral position; Sciatic nerve block, with leg kept in a neutral position after anesthesia (control group)	Other: Sciatic Nerve block; Other: Leg in a neutral position
Experimental: 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	Other: Sciatic Nerve block; Other: Leg raised 30°
Experimental: 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.	Other: Sciatic Nerve block; Other: Leg in a neutral position; Other: Distal tourniquet placed on the lower part of the leg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Evaluation of motor block evaluated by measuring movement on the scale of 0 to 5 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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Levon Capan, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 29, 2017
• Study Completion (Actual): July 10, 2019

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 14-01327

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No