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

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00969423
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Oct 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. QST score [2 years]

2. Post surgical pain [2 years]

Secondary Outcome Measures

1. Patient related factors, depression, coping etc. [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	dk-2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

• Principal Investigator: Kim Wildgaard, MD, Section for Surgical Pathophysiology 4074 Copenhagen, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00969423
• Other Study ID Numbers: H-A-2009-054
• First Posted: Sep 1, 2009
• Last Update Posted: Aug 18, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by , ,: persistent pain; neuropathic pain; Chronic Pain; VATS; Primary spontaneous pneumothorax patients
• Additional relevant MeSH terms: Pneumothorax; Chronic Pain

Study Results

No Results Posted as of Aug 18, 2011