Evaluation of Chronic Pain After Nerve Section During Tho... | NCT00653367

Studies
Evaluation of Chronic Pain After Nerve Section During Thoracotomy

NCT00653367

Sponsor

Rigshospitalet, Denmark

Status

Withdrawn

Last Update Posted

Feb 24, 2012Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

Nerve section

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Apr 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Apr 1, 2008

First Submission Date that Met QC Criteria

Apr 3, 2008

First Posted Date

Apr 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2012

Last Update Posted Date

Feb 24, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NS	Experimental	Nerve section of intercostal nerve during surgery	Procedure: Nerve section
Control	No Intervention	Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nerve section	Procedure	Intercostal nerve is divided during surgery	NS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain (NRS)		3 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kim Wildgaard, MD	Section for Surgical Pathophysiology 4074	Principal Investigator
Henrik Kehlet, MD, Phd, Pro	Section for Surgical Pathophysiology 4074	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Section for Surgical Pathophysiology 4074		Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D000072836	Surgical Wound
D009369	Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided