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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
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
  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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300195

Locations
Denmark
Section for Surgical Pathophysiology 4074
Copenhagen, Denmark, 2100
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016