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

Laval University

Status and phase: Completed; Phase 4

Conditions: Lung Cancer

Treatments: Drug: Saline solution; Drug: Dexamethasone IV

Study type: Interventional

Funder types: Other

Identifiers

NCT02275702

APV-100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

saline solution IV, bolus

Treatment:

Drug: Saline solution

Group 2

Active Comparator group

Description:

0,1mg/kg systemic dose of dexamethasone, bolus

Treatment:

Drug: Dexamethasone IV