Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Dexamethasone IV
* Drug: Saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: resectable stage I and II lung cancer patients submitted to VATS american society of anesthesiology Classification (ASA) I or II Exclusion Criteria: chronic pain; chronic analgesic consumption; severe renal or liver disease; endocrine or mental diseases; poorly controlled diabetes; allergy to bupivacaine; previous thoracotomy; systemic use of corticosteroids; morbid obesity; poor French comprehension precluding completion of the QoR-40 questionnaire; patient refusal.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>saline solution IV, bolus | Drug: Saline solution<br> <br> |
| Active Comparator: Group 2<br>0,1mg/kg systemic dose of dexamethasone, bolus | Drug: Dexamethasone IV<br>* It will be administered at the induction of the anesthesia<br>* Other names: Decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of this study will be postoperative quality of recovery measured by postoperative quality of recovery score 40 (QoR-40) global score. |  | During the hospital stay and 1 year later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of analgesia between the final intercostal nerve block and the first patient-controlled analgesia (PCA) request; |  | During the hospital stay and 1 year later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, Quality of recovery questionnaire, QoR-40, Lung cancer, Video-assisted thoracoscopic