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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Dexamethasone IV

Saline solution

About this trial

This is an interventional other trial for Lung Cancer focused on measuring Dexamethasone, Quality of recovery questionnaire, QoR-40, Lung cancer, Video-assisted thoracoscopic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ
IUCPQ

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

saline solution IV, bolus

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

Outcomes

Primary Outcome Measures

The primary outcome of this study will be postoperative quality of recovery measured by postoperative quality of recovery score 40 (QoR-40) global score.

Secondary Outcome Measures

Time of analgesia between the final intercostal nerve block and the first patient-controlled analgesia (PCA) request;

Full Information

NCT ID

NCT02275702

First Posted

September 23, 2014

Last Updated

August 24, 2021

Sponsor

Laval University

1. Study Identification

Unique Protocol Identification Number

NCT02275702

Brief Title

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

Acronym

APV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

October 2014 (Actual)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laval University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Dexamethasone, Quality of recovery questionnaire, QoR-40, Lung cancer, Video-assisted thoracoscopic

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Placebo Comparator

Arm Description

saline solution IV, bolus

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone IV

Other Intervention Name(s)

Decadron

Intervention Description

It will be administered at the induction of the anesthesia

Intervention Type

Drug

Intervention Name(s)

Saline solution

Primary Outcome Measure Information:

Title

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