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

Primary Purpose

Pneumothorax

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
5mm videoscope
10mm videoscope
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumothorax focused on measuring persistent pain, neuropathic pain, Chronic Pain, VATS, Primary spontaneous pneumothorax patients

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

5 mm equipment

10 mm

Arm Description

5 mm videoscopic equipment

Use of standard 10 mm VATS equipment

Outcomes

Primary Outcome Measures

QST score
Post surgical pain

Secondary Outcome Measures

Patient related factors, depression, coping etc.

Full Information

First Posted
August 31, 2009
Last Updated
August 17, 2011
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00969423
Brief Title
Chronic Pain After Video-assisted Thoracoscopic Surgery (VATS) Surgery for Pneumothorax
Official Title
Chronic Pain After VATS Surgery for Pneumothorax
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
unable to recruit
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
persistent pain, neuropathic pain, Chronic Pain, VATS, Primary spontaneous pneumothorax patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 mm equipment
Arm Type
Experimental
Arm Description
5 mm videoscopic equipment
Arm Title
10 mm
Arm Type
Experimental
Arm Description
Use of standard 10 mm VATS equipment
Intervention Type
Device
Intervention Name(s)
5mm videoscope
Intervention Description
use of 5mm videoscope
Intervention Type
Device
Intervention Name(s)
10mm videoscope
Intervention Description
use of 10mm videoscope
Primary Outcome Measure Information:
Title
QST score
Time Frame
2 years
Title
Post surgical pain
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patient related factors, depression, coping etc.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Wildgaard, MD
Organizational Affiliation
Section for Surgical Pathophysiology 4074 Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
dk-2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19307137
Citation
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.
Results Reference
background

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

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