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

Pneumothorax Clinical Trial

Official title:

Chronic Pain After VATS Surgery for Pneumothorax

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00969423
• Other study ID #: H-A-2009-054
• Status: Terminated
• Phase: N/A
• First received: August 31, 2009
• Last updated: August 17, 2011
• Start date: October 2009

Study information

• Verified date: August 2011
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Pain
• Pneumothorax

Intervention

Device:
• 5mm videoscope
use of 5mm videoscope
• 10mm videoscope
use of 10mm videoscope

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QST score		2 years	No
Primary	Post surgical pain		2 years	No
Secondary	Patient related factors, depression, coping etc.		2 years	No