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Chronic Pain After Video-assisted Thoracoscopic Surgery (VATS) Surgery for Pneumothorax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00969423
Recruitment Status : Terminated (unable to recruit)
First Posted : September 1, 2009
Last Update Posted : August 18, 2011
Information provided by:
Rigshospitalet, Denmark

Brief Summary:
The study will investigate characteristics of chronic pain after VATS surgery with two different sizes of videoscopic equipment.

Condition or disease Intervention/treatment Phase
Pneumothorax Device: 5mm videoscope Device: 10mm videoscope Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Chronic Pain After VATS Surgery for Pneumothorax
Study Start Date : October 2009
Estimated Primary Completion Date : December 2011

Arm Intervention/treatment
Experimental: 5 mm equipment
5 mm videoscopic equipment
Device: 5mm videoscope
use of 5mm videoscope

Experimental: 10 mm
Use of standard 10 mm VATS equipment
Device: 10mm videoscope
use of 10mm videoscope

Primary Outcome Measures :
  1. QST score [ Time Frame: 2 years ]
  2. Post surgical pain [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Patient related factors, depression, coping etc. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • PSP
  • Able to understand and give consent
  • Can read
  • Residing in Denmark

Exclusion Criteria:

  • Unable to understand the written information in Danish
  • Abuse (Medicine, Drugs, Alcohol)
  • Severe psychiatric Illness
  • Conflicting neurological disease
  • Conversion to open surgery
  • Use of neuroaxial analgesia
  • Use of electric cauterizer necessitated
  • Additional thoracic surgery in the investigation period

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 identifier (NCT number): NCT00969423

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Copenhagen, Denmark, dk-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Kim Wildgaard, MD Section for Surgical Pathophysiology 4074 Copenhagen, Denmark

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Responsible Party: Rigshospitalet, Denmark Identifier: NCT00969423     History of Changes
Other Study ID Numbers: H-A-2009-054
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: August 18, 2011
Last Verified: August 2011
Keywords provided by Rigshospitalet, Denmark:
persistent pain
neuropathic pain
Chronic Pain
Primary spontaneous pneumothorax patients
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Signs and Symptoms
Pleural Diseases
Respiratory Tract Diseases