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Evaluation of Chronic Pain After Nerve Section During Thoracotomy

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00653367
First Posted: April 4, 2008
Last Update Posted: February 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose
The purpose of this study is to investigate if controlled nerve section reduces chronic pain after thoracotomy.

Condition Intervention
Lung Cancer Procedure: Nerve section

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Post Thoracotomy Pain After Nerve Section

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Pain (NRS) [ Time Frame: 3 months postoperatively ]

Secondary Outcome Measures:
  • QST parameters (sensory thresholds to cool/Warmth) [ Time Frame: 3 months postoperatively ]
  • Social well-being (HADS / PCS) [ Time Frame: 3 months postoperatively ]
  • Function (pain impairment of Activities of Daily Life) [ Time Frame: 3 months postoperatively ]

Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NS
Nerve section of intercostal nerve during surgery
Procedure: Nerve section
Intercostal nerve is divided during surgery
No Intervention: Control
Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653367


Locations
Denmark
Section for Surgical Pathophysiology 4074
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Kim Wildgaard, MD Section for Surgical Pathophysiology 4074
Study Chair: Henrik Kehlet, MD, Phd, Pro Section for Surgical Pathophysiology 4074
  More Information

Responsible Party: MD Kim Wildgaard, Section for Surgical Pathophysiology 4074
ClinicalTrials.gov Identifier: NCT00653367     History of Changes
Other Study ID Numbers: RH-EKPF-2008-01
First Submitted: April 1, 2008
First Posted: April 4, 2008
Last Update Posted: February 24, 2012
Last Verified: August 2011

Keywords provided by Rigshospitalet, Denmark:
Thoracotomy
Nerve section
QST
Quantitative Sensory Test
Muscle sparing Posterolateral thoracotomy
Chest
Wall
Surgical
Incision
Tumors or cancer of the lung