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

This study has been terminated.
(unable to recruit)
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00969423
First received: August 31, 2009
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention
Pneumothorax
 Device: 5mm videoscope
Device: 10mm videoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Chronic Pain After VATS Surgery for Pneumothorax

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • QST score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Post surgical pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient related factors, depression, coping etc. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969423

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

Additional Information:
Project website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00969423     History of Changes
Other Study ID Numbers: H-A-2009-054
Study First Received: August 31, 2009
Last Updated: August 17, 2011
Health Authority: Denmark: National Board of Health
Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
persistent pain
neuropathic pain
Chronic Pain
VATS
Primary spontaneous pneumothorax patients

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013