Evaluation of Chronic Pain After Nerve Section During Thoracotomy

February 23, 2012 updated by: Rigshospitalet, Denmark

Post Thoracotomy Pain After Nerve Section

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Section for Surgical Pathophysiology 4074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: NS
Nerve section of intercostal nerve during surgery
Procedure: Nerve section
Intercostal nerve is divided during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain (NRS)
Time Frame: 3 months postoperatively
3 months postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Estimate)

February 24, 2012

Last Update Submitted That Met QC Criteria

February 23, 2012

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RH-EKPF-2008-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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