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

August 17, 2011 updated by: Rigshospitalet, Denmark

Chronic Pain After VATS Surgery for Pneumothorax

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QST score
Time Frame: 2 years
2 years
Post surgical pain
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient related factors, depression, coping etc.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

August 31, 2009

First Submitted That Met QC Criteria

August 31, 2009

First Posted (Estimate)

September 1, 2009

Study Record Updates

Last Update Posted (Estimate)

August 18, 2011

Last Update Submitted That Met QC Criteria

August 17, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-A-2009-054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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