Prediction of Persistent Postsurgical Pain After Video-as... | NCT01300195

Studies
Prediction of Persistent Postsurgical Pain After Video-assisted Thoracic Surgery (VATS)

NCT01300195

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Sep 28, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Pain, Postoperative

Interventions

Not provided

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

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Nov 2012Estimated

Completion Date

Apr 2013Estimated

First Submitted Date

Feb 18, 2011

First Submission Date that Met QC Criteria

Feb 18, 2011

First Posted Date

Feb 21, 2011Estimated

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

Sep 27, 2011

Last Update Posted Date

Sep 28, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Name	Class
Dept. of thoracic Surgery	AMBIG
Dept. of cardio-thoracic anaesthesia	AMBIG
Dept. Surgical PAthophysiology	AMBIG
all Blegdamsvej 9, 2100-Copenhagen, Denmark

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

Description Module

Brief Summary

Prospective cohort study of factors predisposing to persistent post surgical pain after video-assisted thoracic surgery

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lung cancer surgery		Patients undergoing video-assisted thoracic surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Persistent post surgical pain	Pain intensity (Numerical Rating Scale)	3 months
Analgesic use	type(s) and amount of analgesics used	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age < 18 years old
Elective lung cancer surgery (VATS)

Exclusion Criteria:

do not understand Danish
cognitive reduction
bilateral procedure planned
previous thoracic surgery
pregnant or nursing
known nerve affection from other cause
alcohol/substance abuse
inability to cooperate to pain scoring/sensory examination
> 5 mg methylprednisolone/day

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Lung cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kim Wildgaard, MD	Contact	+45 3545 3246		wildgaard@thoracotomy.eu

Overall Officials

Not provided

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23328340	Derived	Werner MU, Ringsted TK, Kehlet H, Wildgaard K. Sensory testing in patients with postthoracotomy pain syndrome: Part 1: mirror-image sensory dysfunction. Clin J Pain. 2013 Sep;29(9):775-83. doi: 10.1097/AJP.0b013e318277b646.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain