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

Not Applicable

Completed

• Conditions: Sensory Nerve Conduction; Oxyneurogram Index

• Registration Number: NCT01970839
• Lead Sponsor: Duke University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-28
• Study Start: 2014-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in sensory nerve conduction	baseline, 5 minutes
Changes in oxyneurogram index	baseline, 5 minutes

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States