Carpal Tunnel Release Effects on Median Nerve Perfusion

Effect of Carpal Tunnel Release on Median Nerve Perfusion Using SPY Scope Imaging

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.

Study Overview

• Status: Withdrawn
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: 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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Indigocyanine green dye (ICG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of median nerve perfusion with carpal tunnel release	This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging.	intraoperatively

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Nadia M Obeid, MD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (Estimate): June 4, 2012

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: HFHSobeid2012

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