NCT02275702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_4 lung-cancer

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

September 23, 2014

Last Update Submit

August 24, 2021

Conditions

Lung Cancer

Keywords

DexamethasoneQuality of recovery questionnaireQoR-40Lung cancerVideo-assisted thoracoscopic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Other Outcomes (3)

  • 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)

    During the hospital stay and 1 year later

  • Total opioid dose consumption in each group

    During the hospital stay and 1 year later

  • Side-effect of dexamethasone in the stress response to surgery

    During the hospital stay and 1 year later

Study Arms (2)

Group 1

PLACEBO COMPARATOR

saline solution IV, bolus

Drug: Saline solution

Group 2

ACTIVE COMPARATOR

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

Drug: Dexamethasone IV

Interventions

Dexamethasone IVDRUG

It will be administered at the induction of the anesthesia

Also known as: Decadron
Group 2
Saline solutionDRUG
Group 1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • resectable stage I and II lung cancer patients submitted to VATS
  • american society of anesthesiology Classification (ASA) I or II

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ

Québec, G1v 4G5, Canada

Location

IUCPQ

Québec, G1V3H8, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Calcium DobesilateSaline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Paula A. Ugalde, Medicin

    Institut Universitaire de Cardilogie et Pneumologie de Québec, IUCPQ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

October 27, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

CA(2)