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

August 24, 2021 updated by: Laval University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1v 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ
      • Québec, Canada, G1V3H8
        • IUCPQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 1
saline solution IV, bolus
Drug: Saline solution
Active Comparator: Group 2
0,1mg/kg systemic dose of dexamethasone, bolus
Drug: Dexamethasone IV
It will be administered at the induction of the anesthesia
Other Names:
  • Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: During the hospital stay and 1 year later
During the hospital stay and 1 year later

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: During the hospital stay and 1 year later
During the hospital stay and 1 year later
Total opioid dose consumption in each group
Time Frame: During the hospital stay and 1 year later
During the hospital stay and 1 year later
Side-effect of dexamethasone in the stress response to surgery
Time Frame: During the hospital stay and 1 year later
During the hospital stay and 1 year later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Paula A. Ugalde, Medicin, Institut Universitaire de Cardilogie et Pneumologie de Québec, IUCPQ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APV-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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