Lung CancerPhase 4APVNCT02275702
Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients
A Phase 4 study testing Dexamethasone IV and Saline solution in people with Lung Cancer, run by Laval University at 2 sites in Canada.
Trial summary
The proposed study is a randomized, double-blind, placebo-controlled evaluation if a small dose of IV dexamethasone during induction anesthesia in association to pre and postoperative intercostal nerve block, improves quality of recovery of thoracoscopic lung resection patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Dexamethasone IV and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2014to Dec 2016
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- resectable stage I and II lung cancer patients submitted to VATS
- american society of anesthesiology Classification (ASA) I or II
Who cannot join
- chronic pain;
- chronic analgesic consumption;
- severe renal or liver disease;
- endocrine or mental diseases;
- poorly controlled diabetes;
- allergy to bupivacaine;
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- previous thoracotomy;
- systemic use of corticosteroids;
- morbid obesity;
- poor French comprehension precluding completion of the QoR-40 questionnaire;
- patient refusal.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ
Québec, G1v 4G5
IUCPQ
Québec, G1V3H8
About this study
The proposed study is a randomized, double-blind, placebo-controlled evaluation if a small dose of IV dexamethasone during induction anesthesia in association to pre and postoperative intercostal nerve block, improves quality of recovery of thoracoscopic lung resection patients.
Read the detailed description
This is a study composed by 2 groups of 50 patients undergoing VATS for lung cancer. All subjets will receive intraoperative intercostal nerve block with a maximum dose of 2 mg/kg of bupivacaine with epinephrine 1:200.000 at the beginning and at the end of procedure.
The control group will receive a bolus dose of dexamethasone (0.1 mg/kg) and the placebo group saline solution. The study drug or placebo will be administered at the time of anesthetic induction (approximately 30 minutes before surgical incision). Patients will be evaluated daily with the quality of recovery questionary, visual analogue pain and portable spirometry. And, the patients will have pulmonary lung function assessed by portable spirometry.
- Conditions
- Lung Cancer
- Being tested
- Dexamethasone IV, Saline solution
- Keywords
- Dexamethasone, Quality of recovery questionnaire, QoR-40, Lung cancer, Video-assisted thoracoscopic
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone IVDrug
Also called Decadron
It will be administered at the induction of the anesthesia
Saline solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | saline solution IV, bolus Receives: Drug: Saline solution |
| Group 2 | Active comparator | 0,1mg/kg systemic dose of dexamethasone, bolus Receives: Drug: Dexamethasone IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study will be postoperative quality of recovery measured by postoperative quality of recovery score 40 (QoR-40) global score.
Measured: During the hospital stay and 1 year later
Secondary outcomes (1)
Time of analgesia between the final intercostal nerve block and the first patient-controlled analgesia (PCA) request;
Measured: During the hospital stay and 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula A. Ugalde, Medicin, Principal investigator, Institut Universitaire de Cardilogie et Pneumologie de Québec, IUCPQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275702
- Sponsor's protocol ID
- APV-100
- Acronym
- APV
- Status last verified
- Aug 2021
- First submitted
- 23 Sep 2014
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients
- ClinicalTrials.gov ID
- NCT02275702
- Acronym / sponsor ID
- APV / APV-100
- Conditions
- Lung Cancer
- Keywords
- Dexamethasone, Quality of recovery questionnaire, QoR-40, Lung cancer, Video-assisted thoracoscopic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Oct 2014 (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.
The proposed study is a randomized, double-blind, placebo-controlled evaluation if a small dose of IV dexamethasone during induction anesthesia in association to pre and postoperative intercostal nerve block, improves quality of recovery of thoracoscopic lung resection patients.
Detailed description
This is a study composed by 2 groups of 50 patients undergoing VATS for lung cancer. All subjets will receive intraoperative intercostal nerve block with a maximum dose of 2 mg/kg of bupivacaine with epinephrine 1:200.000 at the beginning and at the end of procedure.
The control group will receive a bolus dose of dexamethasone (0.1 mg/kg) and the placebo group saline solution. The study drug or placebo will be administered at the time of anesthetic induction (approximately 30 minutes before surgical incision). Patients will be evaluated daily with the quality of recovery questionary, visual analogue pain and portable spirometry. And, the patients will have pulmonary lung function assessed by portable spirometry.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: Saline solutionsaline solution IV, bolus |
| Group 2 | Active comparator | Drug: Dexamethasone IV0,1mg/kg systemic dose of dexamethasone, bolus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- resectable stage I and II lung cancer patients submitted to VATS
- american society of anesthesiology Classification (ASA) I or II
Key exclusion criteria (11 listed)
- chronic pain;
- chronic analgesic consumption;
- severe renal or liver disease;
- endocrine or mental diseases;
- poorly controlled diabetes;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone IVAlso: DecadronIt will be administered at the induction of the anesthesia | Drug | Group 2 |
| Saline solution | Drug | Group 1 |
Primary outcome
The primary outcome of this study will be postoperative quality of recovery measured by postoperative quality of recovery score 40 (QoR-40) global score.
Time frame: During the hospital stay and 1 year later
1 secondary outcome
Time of analgesia between the final intercostal nerve block and the first patient-controlled analgesia (PCA) request;
Time frame: During the hospital stay and 1 year later
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 25 Aug 2021.
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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.
Paula A. Ugalde, Medicin principal investigator
Institut Universitaire de Cardilogie et Pneumologie de Québec, IUCPQ
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone IV and Saline solution in people with Lung Cancer, run by Laval University at 2 sites in Canada.
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 11 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 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome of this study will be postoperative quality of recovery measured by postoperative quality of recovery score 40 (QoR-40) global score. (time frame: During the hospital stay and 1 year later). 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 25 Aug 2021.