Cancer pulmones
Conditions
Interventions
Trade Name: Bupivacain
Product Name: Bupivacain
Product Code: N01BB01
Pharmaceutical Form: Infusion
Sponsors
Prof. Peter Licht
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Immonological aspects of use of epidural analgesia for VATS. ;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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of surgery. Length of hospital stay. Time used placing epidural catheter. Procedural time and competence level of MD placing catheter. Side effects of epidural analgesia. Side effects observed using epidural analgesia including itching, nausea, vomiting, procedural pain, hypotension, dizziness, respiratory depression, reduced pulmonary function. Sequelae following VATS and placement of epidural catheter (Questionnaire and Postoperative survival). Questionnaire sent to patients 6, 12, 24 and 60 months after surgery (criteria edited as part of a protocol amendment July 27th 2016 for a subsequent biomarkers study). Immune cells . Time Frame: During surgery and one hour and 24 hours after surgery, and compared with pre-operative levels. NK-cells (levels and activity) will be examined as indicators of immunological response to surgery. Cytokines. Time Frame: During surgery and one hour and 24 hours after surgery, and compared with pre-operative levels. Levels of cytokines (IL-6, IL-10, IL-12 and IFN-gamma) will be examined as indicators of immunological response to surgery. ;Timepoint(s) of evaluation of this end point: During in-hospital stay (POD 0-4). For the questionnaire and survival part of the study the time frame is 60 months. | — |
Countries
Denmark
Contacts
Public ContactAfd. V - Odense University Hospital
Odense University Hospital
Outcome results
None listed