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

Lung Cancer Clinical Trial

— APV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275702
• Other study ID #: APV-100
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2021
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Dexamethasone IV
It will be administered at the induction of the anesthesia
• Saline solution

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ	Québec
Canada	IUCPQ	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Total opioid dose consumption in each group		During the hospital stay and 1 year later
Other	Side-effect of dexamethasone in the stress response to surgery		During the hospital stay and 1 year later
Primary	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	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