NCT02688439

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

2.8 years

First QC Date

January 20, 2016

Last Update Submit

August 1, 2019

Conditions

Sciatic Nerve

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Leg in a neutral position

ACTIVE COMPARATOR

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

Other: Sciatic Nerve blockOther: Leg in a neutral position

Leg raised 30°

EXPERIMENTAL

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 blockOther: Leg raised 30°

Distal tourniquet placed on the lower part of the leg

EXPERIMENTAL

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 blockOther: Distal tourniquet placed on the lower part of the legOther: Leg in a neutral position

Interventions

Sciatic Nerve blockOTHER
Distal tourniquet placed on the lower part of the legLeg in a neutral positionLeg raised 30°
Leg raised 30°OTHER
Leg raised 30°
Distal tourniquet placed on the lower part of the legOTHER
Distal tourniquet placed on the lower part of the leg
Leg in a neutral positionOTHER
Distal tourniquet placed on the lower part of the legLeg in a neutral position

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

  • Levon Capan, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

February 23, 2016

Study Start

March 1, 2015

Primary Completion

December 29, 2017

Study Completion

July 10, 2019

Last Updated

August 5, 2019

Record last verified: 2019-08

Locations

US(1)