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Prediction of Persistent Postsurgical Pain After Video-assisted Thoracic Surgery (VATS)

This study is currently recruiting participants.
Verified September 2011 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
Dept. of thoracic Surgery
Dept. of cardio-thoracic anaesthesia
Dept. Surgical PAthophysiology
all Blegdamsvej 9, 2100-Copenhagen, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01300195
First received: February 18, 2011
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  Purpose

Prospective cohort study of factors predisposing to persistent post surgical pain after video-assisted thoracic surgery


Condition
Pain, Postoperative

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Predicting Persistent Post-surgical Pain After Video-assisted Thoracic Surgery (VATS)

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Persistent post surgical pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pain intensity (Numerical Rating Scale)

  • Analgesic use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    type(s) and amount of analgesics used


Biospecimen Retention:   Samples With DNA

whole blood used to detect genetic polymorphism


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
lung cancer surgery
Patients undergoing video-assisted thoracic surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Lung cancer patients

Criteria

Inclusion Criteria:

  • Age < 18 years old
  • Elective lung cancer surgery (VATS)

Exclusion Criteria:

  • do not understand Danish
  • cognitive reduction
  • bilateral procedure planned
  • previous thoracic surgery
  • pregnant or nursing
  • known nerve affection from other cause
  • alcohol/substance abuse
  • inability to cooperate to pain scoring/sensory examination
  • > 5 mg methylprednisolone/day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300195

Contacts
Contact: Kim Wildgaard, MD +45 3545 3246 wildgaard@thoracotomy.eu

Locations
Denmark
Section for Surgical Pathophysiology 4074 Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Kim Wildgaard, MD            
Sub-Investigator: Thomas Ringsted, Md            
Sponsors and Collaborators
Rigshospitalet, Denmark
Dept. of thoracic Surgery
Dept. of cardio-thoracic anaesthesia
Dept. Surgical PAthophysiology
all Blegdamsvej 9, 2100-Copenhagen, Denmark
  More Information

Additional Information:
Study webpage (mostly in Danish)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: MD, Kim Wildgaard, Section for Surgical Pathophysiology 4074
ClinicalTrials.gov Identifier: NCT01300195     History of Changes
Other Study ID Numbers: H4-2010-118#0
Study First Received: February 18, 2011
Last Updated: September 27, 2011
Health Authority: Denmark: Danish Board of Health

Keywords provided by Rigshospitalet, Denmark:
VATS
standardized surgery
persistent pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013