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Carpal Tunnel Release Effects on Median Nerve Perfusion

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ClinicalTrials.gov Identifier: NCT01610739
Recruitment Status : Unknown
Verified July 2012 by Nadia M. Obeid, MD, Henry Ford Health System.
Recruitment status was:  Not yet recruiting
First Posted : June 4, 2012
Last Update Posted : July 19, 2012
Information provided by (Responsible Party):
Nadia M. Obeid, MD, Henry Ford Health System

Brief Summary:
This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging to view the perfusion to the nerve.

Condition or disease Intervention/treatment
Carpal Tunnel Syndrome Drug: Indigocyanine green dye

Detailed Description:
The study will involve patients undergoing carpal tunnel release surgery at our institution, with no change in the actual procedure performed. Using the SPY Scope, we will measure blood flow prior to the carpal tunnel release, and again measure once carpal tunnel release has been performed, in order to compare the values. This may add roughly 15 minutes to the total procedure time, however, no steps in the actual operation will be altered or affected in any way.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effect of Carpal Tunnel Release on Median Nerve Perfusion Using SPY Scope Imaging
Study Start Date : July 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Arm Intervention/treatment
Median nerve perfusion
Injection of indigocyanine green dye to evaluate perfusion of the median nerve with the SPY scope before and after carpal tunnel release
Drug: Indigocyanine green dye
Each patient will receive 1 injection of indigocyanine green dye using 2.5 mg/mL concentration of the imaging agent. 3mL of this mixture will be injected intravenously, followed by 10mL NS bolus, just prior to imaging with the SPY scope
Other Name: Indigocyanine green dye (ICG)

Primary Outcome Measures :
  1. Effect of median nerve perfusion with carpal tunnel release [ Time Frame: intraoperatively ]
    This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • carpal tunnel syndrome
  • 18 years or older

Exclusion Criteria:

  • pregnant
  • less than 18 years of age
  • allergy to iodide or iodinated contrast agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610739

Contact: Nadia M Obeid, M.D. 2487090067 nobeid1@hfhs.org
Contact: Kenneth Moquin, M.D. 3139162676 kmoquin1@hfhs.org

United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Nadia M Obeid, M.D.         
Sub-Investigator: Kenneth Moquin, M.D.         
Sponsors and Collaborators
Henry Ford Health System
Principal Investigator: Nadia M Obeid, MD Henry Ford Health System

Responsible Party: Nadia M. Obeid, MD, M.D., Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01610739     History of Changes
Other Study ID Numbers: HFHSobeid2012
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: July 19, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries