NCT01213654

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

Enrollment Period

5 months

First QC Date

October 1, 2010

Last Update Submit

October 1, 2010

Conditions

Keywords

Lung cancerVATS Lobectomy

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Side effects (quantitatively, see details)

    until discharge, 2-4 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consenting lung cancer patients due for elective surgery

You may qualify if:

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

You may not qualify if:

  • do not understand DAnish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 4, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations