Effect of Tourniquet on Sensory Nerve Conduction Threshold (sNCT) and OxyNeuroGram (ONG) Index- A Volunteer Study

NCT ID: NCT01970839

Last Updated: 2017-03-21

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-04-30

Brief Summary

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There are a number of risk factors for development of chronic pain that have been evaluated including age, gender, type and duration of surgery, duration of pain prior to surgery and tourniquet application. There is some scientific evidence from animal studies demonstrating that prolonged tourniquet application can result in lack of oxygen supply to nerves, and subsequent nerve damage resulting in chronic pain. This theory has not been proven in humans. In this study the investigators will indirectly assess the evidence for abnormalities caused by tourniquet application on subjects' nerves using well established devices to determine the function of these nerves.

Detailed Description

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Conditions

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Sensory Nerve Conduction Oxyneurogram Index

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tourniquet, pain, nerve injury, sensory nerve function

Group Type OTHER

tourniquet, sensory nerve conduction abnormality

Intervention Type DEVICE

Interventions

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tourniquet, sensory nerve conduction abnormality

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy adults
* Over 18 years of age

Exclusion Criteria

* Neurological disease
* Diabetes mellitus
* History of nerve injury
* Chronic pain
* Alcoholism
* Blood pressure measurements greater than 140/80 and infection in the monitored area
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Srini Pyati, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00048542

Identifier Type: -

Identifier Source: org_study_id

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