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

March 20, 2017 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tourniquet, pain, nerve injury, sensory nerve function
Device: tourniquet, sensory nerve conduction abnormality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in sensory nerve conduction
Time Frame: baseline, 5 minutes
baseline, 5 minutes
Changes in oxyneurogram index
Time Frame: baseline, 5 minutes
baseline, 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Srini Pyati, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00048542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sensory Nerve Conduction

Clinical Trials on tourniquet, sensory nerve conduction abnormality

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe