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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02275702
Acronym
APV
Enrollment
100
Registered
2014-10-27
Start date
2014-10-31
Completion date
2016-12-31
Last updated
2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

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

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.

Interventions

It will be administered at the induction of the anesthesia

DRUGSaline solution

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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.During the hospital stay and 1 year later

Secondary

MeasureTime frame
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

MeasureTime 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)During the hospital stay and 1 year later
Total opioid dose consumption in each groupDuring the hospital stay and 1 year later
Side-effect of dexamethasone in the stress response to surgeryDuring the hospital stay and 1 year later

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026