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Sensory Mapping Following Video-assisted Thoracic Surgery

This study is currently recruiting participants.
Verified January 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Kim Wildgaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01375283
First received: June 15, 2011
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

This is a prospective observational cohort study on changes in sensory mapping.


Condition
Paresthesia
Dysesthesia
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensory Mapping Following Video-assisted Thoracic Surgery

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Area (cm2) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Size of sensory dysfunction


Secondary Outcome Measures:
  • Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    pain intensity /numerical rating scale)


Estimated Enrollment: 48
Study Start Date: June 2011
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
lung cancer surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing video-assisted thoracic surgery

Criteria

Inclusion Criteria:

  • Age < 18 years old
  • Elective lung cancer surgery (VATS)

Exclusion Criteria:

  • does not understand Danish
  • cognitive reduction
  • bilateral procedure planned
  • previous thoracic surgery
  • pregnant or nursing
  • known nerve affection from other cause
  • alcohol/substance abuse
  • inability to cooperate to pain scoring/sensory examination
  • > 5 mg methylprednisolone/day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375283

Contacts
Contact: Kim Wildgaard, MD +45 3545 3246 wildgaard@thoracotomy.eu

Locations
Denmark
Section for Surgical Pathophysiology 4074 Recruiting
Copenhagen, Denmark, 2100
Contact: Kim Wildgaard     35454236        
Principal Investigator: Kim Wildgaard, MD            
Sub-Investigator: Thomas Ringsted, Research nurse            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Mads Werner, MD, Multidisciplinary Pain Center
Principal Investigator: Kim Wildgaard Section for Surgical Pathophysiology
Study Director: Henrik Kehlet, MD Section for Surgical Pathophysiology
  More Information

No publications provided

Responsible Party: Kim Wildgaard, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01375283     History of Changes
Other Study ID Numbers: H4-2010-118#2
Study First Received: June 15, 2011
Last Updated: January 4, 2012
Health Authority: Denmark: Danish Board of Health

Additional relevant MeSH terms:
Paresthesia
Somatosensory Disorders
Sensation Disorders
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013