Evaluation of Chronic Pain After Nerve Section During Thoracotomy

This study is not yet open for participant recruitment.

Verified by Rigshospitalet, Denmark, September 2008

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00653367

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

MedlinePlus related topics: Cancer Lung Cancer

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Post Thoracotomy Pain After Nerve Section

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Pain [ Time Frame: 3,6,12 mths postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	48
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
NS: Experimental Nerve section of intercostal nerve during surgery	Procedure: Nerve section Inter costal nerve is divided during surgery
Control: No Intervention Control

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653367

Contacts

Contact: Kim Wildgaard, MD

0045 35458317

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:	Section for Surgical Pathophysiology 4074 ( MD Kim Wildgaard )
Study ID Numbers:	RH-EKPF-2008-01
Study First Received:	April 1, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00653367
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

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Pain

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009