Lung Cancer PatientsNCT01213654
Inter Costal Catheters for Video-Assisted Thoroscopic (VATS) Lobectomy
An observational study of Lung Cancer Patients, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
A pilot study to observe satisfaction of analgesia with intercostal catheters after VATS lobectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Patients
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consenting lung cancer patients due for elective surgery
Who may be able to join
- Age of consent (ie age>=18) Eligible for lobectomy Able to comply Willing to register postoperatively
- -
Who cannot join
- do not understand DAnish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Relief After VATS Lobectomy Using Interoperatively Placed Inter Costal Catheters.
A pilot study to observe satisfaction of analgesia with intercostal catheters after VATS lobectomy.
Read the detailed description
Pain and satisfaction with pain treatment is investigated in a population after VATS lobectomy.
- Conditions
- Lung Cancer Patients
- Keywords
- Lung cancer, VATS Lobectomy
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (pain score 0-10))
Painscore
Measured: Until discharge (2-4 days)
satisfaction (Verbal ranking scale 1-4)
qualitative measurement
Measured: until discharge, 2-4 days
Secondary outcomes (1)
Side effects (quantitatively, see details)
Daily presence of, Nausea Dizziness Vomiting Sedation Pruritus
Measured: until discharge, 2-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Dept. of thoracic Surgery, Dept. of cardio-thoracic anaesthesia, Dept. Surgical PAthophysiology, all Blegdamsvej 9, 2100-Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213654
- Sponsor's protocol ID
- VATS-IC-2010
- Status last verified
- Oct 2010
- First submitted
- 1 Oct 2010
- Last updated
- 4 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief After VATS Lobectomy Using Interoperatively Placed Inter Costal Catheters.
- ClinicalTrials.gov ID
- NCT01213654
- Acronym / sponsor ID
- VATS-IC-2010
- Conditions
- Lung Cancer Patients
- Keywords
- Lung cancer, VATS Lobectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Dept. of thoracic Surgery, Dept. of cardio-thoracic anaesthesia, Dept. Surgical PAthophysiology, all Blegdamsvej 9, 2100-Copenhagen, Denmark
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consenting lung cancer patients due for elective surgery
Key inclusion criteria (2 listed)
- Age of consent (ie age>=18) Eligible for lobectomy Able to comply Willing to register postoperatively
- -
Key exclusion criteria (1 listed)
- do not understand DAnish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NRS (pain score 0-10))
Time frame: Until discharge (2-4 days)
Painscore
satisfaction (Verbal ranking scale 1-4)
Time frame: until discharge, 2-4 days
qualitative measurement
1 secondary outcome
Side effects (quantitatively, see details)
Time frame: until discharge, 2-4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Patients, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (pain score 0-10)) (time frame: Until discharge (2-4 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2010.