ecessity of epidural analgesia in video-assisted thoracic surgery.

Phase 1

• Conditions: Cancer pulmones; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2014-000760-18-DK
• Lead Sponsor: Prof. Peter Licht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-21
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Planned elective VATS lobectomy, wedge- or segmental resection (for the subsequent biomarker study, only lobectomy is a inclusion criteria, specified in protocol amendment July 27th 2016).
Patient has accepted to have epidural analgesia as part of the anaesthesia for the procedure.
Informed consent is attained.
Patient is over 18 years of age.
Patient is mentally able to answer questionnaires included in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

Allergies to any of the medications used in the trial.
History of previous peptic ulcer.
History of chronic pain to any degree that will interfere with quantification of pain postoperatively.
Dementia or reduced mental capacity to any degree that will interfere with quantification of pain postoperatively.
Pregnancy.
Contra-indications to placement of epidural catheter.
Any concurrent cancer disease or use of immune modulating drugs (criteria added as part of a protocol amendment July 27th 2016 for a subsequent biomarkers study)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To see if Video-Assisted Thoracic Surgery (VATS) lobectomy, wedge- or segmental resection can be done without epidural analgesia with no or only minor side effects.;Secondary Objective: Side effects of thoracic epidural analgesia.<br>Immonological aspects of use of epidural analgesia for VATS.<br><br>;Primary end point(s): 1) Intensity of pain. Self reported pain intensity 5 times a day both at rest and during activity until chest tube is removed or day 4 after operation is reached.<br><br>2) Consumption Rescue Analgesia - i.v. opioids. The consumption of i.v. opioids is registered daily until chest tube is removed or day 4 after operation is reached.;Timepoint(s) of evaluation of this end point: Postoperative day 0 to 4.