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Completed

NCT Number: NCT02275702

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IUCPQ, Québec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone IV

Drug

It will be administered at the induction of the anesthesia

Other names: Decadron

Saline Solution

Drug

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.

    Time frame: 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;

    Time frame: During the hospital stay and 1 year later

Other outcomes

  1. 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

  2. Total opioid dose consumption in each group

    Time frame: During the hospital stay and 1 year later

  3. Side-effect of dexamethasone in the stress response to surgery

    Time frame: During the hospital stay and 1 year later

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Acronym: APV

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2014
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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