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

Phase 4

Completed

• Conditions: Lung Cancer
• Interventions: Drug: Saline solution; Drug: Dexamethasone IV

• Registration Number: NCT02275702
• Lead Sponsor: Laval University

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.

Study Timeline

• Study First Submitted: 2014-09-23
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-27
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Saline solution	saline solution IV, bolus
Group 2	Dexamethasone IV	0,1mg/kg systemic dose of dexamethasone, bolus

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ; 🇨🇦 Québec, Canada

IUCPQ; 🇨🇦 Québec, Canada