Inter Costal Catheters for Video-Assisted Thoroscopic (VA... | NCT01213654

Studies
Inter Costal Catheters for Video-Assisted Thoroscopic (VATS) Lobectomy

NCT01213654

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Oct 4, 2010Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Lung Cancer Patients

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

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Oct 1, 2010

First Submission Date that Met QC Criteria

Oct 1, 2010

First Posted Date

Oct 4, 2010Estimated

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

Oct 1, 2010

Last Update Posted Date

Oct 4, 2010Estimated

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

A pilot study to observe satisfaction of analgesia with intercostal catheters after VATS lobectomy.

Detailed Description

Pain and satisfaction with pain treatment is investigated in a population after VATS lobectomy.

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

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NRS (pain score 0-10))	Painscore	Until discharge (2-4 days)
satisfaction (Verbal ranking scale 1-4)	qualitative measurement	until discharge, 2-4 days

Secondary Outcomes

Measure	Description	Time Frame
Side effects (quantitatively, see details)	Daily presence of, Nausea Dizziness Vomiting Sedation Pruritus	until discharge, 2-4 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of consent (ie age>=18) Eligible for lobectomy Able to comply Willing to register postoperatively

Exclusion Criteria:

do not understand DAnish

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

Consenting lung cancer patients due for elective surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided