Evaluation of Chronic Pain After Nerve Section During Thoracotomy

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00653367
First received: April 1, 2008
Last updated: February 23, 2012
Last verified: August 2011

April 1, 2008
February 23, 2012
December 2011
April 2012   (final data collection date for primary outcome measure)
Pain (NRS) [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
Pain [ Time Frame: 3,6,12 mths postoperatively ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00653367 on ClinicalTrials.gov Archive Site
  • QST parameters (sensory thresholds to cool/Warmth) [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • Social well-being (HADS / PCS) [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • Function (pain impairment of Activities of Daily Life) [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • QST parameters [ Time Frame: 3,6,12 moths ] [ Designated as safety issue: No ]
  • Social wellbeing [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
  • Function [ Time Frame: 3,6,12 moths ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of Chronic Pain After Nerve Section During Thoracotomy
Post Thoracotomy Pain After Nerve Section

The purpose of this study is to investigate if controlled nerve section reduces chronic pain after thoracotomy.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Lung Cancer
Procedure: Nerve section
Intercostal nerve is divided during surgery
  • Experimental: NS
    Nerve section of intercostal nerve during surgery
    Intervention: Procedure: Nerve section
  • No Intervention: Control
    Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients included for anterior or lateral thoracotomy

Exclusion Criteria:

  • Unable to give consent due to age, cognitive reduction or otherwise
  • Neurological disease or symptoms affection thoracic area
  • Chronic pain prior to surgery
  • Inability to supply the patient with an epidural catheter
  • Pneumonectomy
  • Prolonged infection at surgical site
  • Invasive tumor growth
  • Need for repeated surgery at site
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00653367
RH-EKPF-2008-01
No
MD Kim Wildgaard, Section for Surgical Pathophysiology 4074
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Kim Wildgaard, MD Section for Surgical Pathophysiology 4074
Study Chair: Henrik Kehlet, MD, Phd, Pro Section for Surgical Pathophysiology 4074
Rigshospitalet, Denmark
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP