Sensory Mapping Following Video-assisted Thoracic Surgery

January 4, 2012 updated by: Kim Wildgaard, Rigshospitalet, Denmark
This is a prospective observational cohort study on changes in sensory mapping.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Section for Surgical Pathophysiology 4074
        • Contact:
          • Kim Wildgaard
          • Phone Number: 35454236
        • Principal Investigator:
          • Kim Wildgaard, MD
        • Sub-Investigator:
          • Thomas Ringsted, Research nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing video-assisted thoracic surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
lung cancer surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area (cm2)
Time Frame: 3 months
Size of sensory dysfunction
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 3 months
pain intensity /numerical rating scale)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Henrik Kehlet, MD, Section for Surgical Pathophysiology
  • Study Chair: Mads Werner, MD,, Multidisciplinary Pain Center
  • Principal Investigator: Kim Wildgaard, Section for Surgical Pathophysiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

June 15, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H4-2010-118#2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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