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This study has been withdrawn prior to enrollment.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
  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:


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
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: 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 July 29, 2014