Clinical trial NCT02275702: Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients
Official title: Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Cancer
Keywords: Dexamethasone
Quality of recovery questionnaire
QoR-40
Lung cancer
Video-assisted thoracoscopic
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: During the hospital stay and 1 year later
Secondary outcomes:
measure: Time of analgesia between the final intercostal nerve block and the first patient-controlled analgesia (PCA) request;
timeFrame: During the hospital stay and 1 year later
Other outcomes:
measure: Correlation between pain with visual analog scale and lung function through spirometry test with forced expiratory volume at one second (FEV1) and diffusion capacity (DLCO)
timeFrame: During the hospital stay and 1 year later
measure: Total opioid dose consumption in each group
timeFrame: During the hospital stay and 1 year later
measure: Side-effect of dexamethasone in the stress response to surgery
timeFrame: During the hospital stay and 1 year later
Locations:
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ
city: Québec
country: Canada
facility: IUCPQ
Study officials:
affiliation: Institut Universitaire de Cardilogie et Pneumologie de Québec, IUCPQ
name: Paula A. Ugalde, Medicin
role: PRINCIPAL_INVESTIGATOR
References: