NCT00653367

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
3.7 years until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 24, 2012

Status Verified

August 1, 2011

Enrollment Period

4 months

First QC Date

April 1, 2008

Last Update Submit

February 23, 2012

Conditions

Lung Cancer

Keywords

ThoracotomyNerve sectionQSTQuantitative Sensory TestMuscle sparing Posterolateral thoracotomyChestWallSurgicalIncisionTumors or cancer of the lung

Outcome Measures

Primary Outcomes (1)

  • Pain (NRS)

    3 months postoperatively

Secondary Outcomes (3)

  • QST parameters (sensory thresholds to cool/Warmth)

    3 months postoperatively

  • Social well-being (HADS / PCS)

    3 months postoperatively

  • Function (pain impairment of Activities of Daily Life)

    3 months postoperatively

Study Arms (2)

NS

EXPERIMENTAL

Nerve section of intercostal nerve during surgery

Procedure: Nerve section

Control

NO INTERVENTION

Control

Interventions

Nerve sectionPROCEDURE

Intercostal nerve is divided during surgery

NS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients included for anterior or lateral thoracotomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section for Surgical Pathophysiology 4074

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Lung NeoplasmsSurgical WoundNeoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesWounds and Injuries

Study Officials

  • Kim Wildgaard, MD

    Section for Surgical Pathophysiology 4074

    PRINCIPAL INVESTIGATOR

  • Henrik Kehlet, MD, Phd, Pro

    Section for Surgical Pathophysiology 4074

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 4, 2008

Study Start

December 1, 2011

Primary Completion

April 1, 2012

Study Completion

December 1, 2012

Last Updated

February 24, 2012

Record last verified: 2011-08

Locations

DK(1)