Trial record 17 of 56 for:    "primary spontaneous pneumothorax" OR "pneumothorax" OR "spontaneous pneumothorax"

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Chronic Pain
Pneumothorax
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014