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OpenTrials
Completed

NCT Number: NCT01970839

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tourniquet, sensory nerve conduction abnormality

Device

Primary outcomes

  1. Changes in sensory nerve conduction

    Time frame: baseline, 5 minutes

  2. Changes in oxyneurogram index

    Time frame: baseline, 5 minutes

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2013
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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