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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This study has been withdrawn prior to enrollment.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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Post Thoracotomy Pain After Nerve Section

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Pain (NRS) [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 1, 2008
Last Updated: February 23, 2012
Health Authority: Denmark: National Board of Health
Denmark: De Videnskabsetiske Komiteer for Region Hovedstaden

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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013