A Phase 4 interventional study of Bupivacaine in epidural catheter and Fentanyl in epidural catheter in Lung Neoplasms, Pain and Immune Suppression, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Odense University Hospital · Phase 4, Interventional, and Treatment
Whereas it, in the case of conventional thoracotomy, has been demonstrated that thoracic epidural analgesia is more effective than systemic opioids in terms of pain relief and preservation of postoperative pulmonary function, the efficacy of epidural analgesia in video-assisted thoracic surgical (VATS) procedures, has not been sufficiently studied, but a beneficial effect might very well be present.
On the other hand, the risks associated with placement of a thoracic epidural catheter are well known and if similar pain relief can be achieved without it with no or only insignificant alternative side effects, this would be preferable.
The literature regarding the usefulness of epidural analgesia for reducing pain in Video-Assisted Thoracic Surgery is, at best, scarce with two small studies showing some effect and two showing no difference, none of the studies being blinded randomized controlled trials of adequate size.
The SEAVATS Study will try to answer this question.
Study plan:
The hypothesis is that there is no difference in the amount of pain the patients will experience after VATS for pulmonary neoplasms.
Study design and setting:
The project is designed as a prospectively, double blinded, randomized, placebo controlled study comparing pain in two groups of patients.
Both groups of patients will:
One group of patients will be given local anaesthetics through the epidural catheter supplemented with placebo medication orally while the other group will receive saline in the epidural catheter supplemented with opioids orally.
Data collection:
Data will, during hospitalization, be collected in the operating theatre, in the postoperative care unit and in the surgical ward. Six months after surgery a questionnaire will be send to the patients to do follow-up regarding residual sequelae after surgery and placement of epidural catheter. Further follow-up with questionnaire has been planned for subsequent years.
As a secondary objective, in fifty-six of the patients from The SEAVATS Study, blood samples will be gathered during surgery and one hour and 24 hours after surgery, and compared with pre-operative levels.
These blood samples will be analysed for immune cells (NK-cells, levels and activity) and cytokines (IL-6, IL-10, IL-12 and IFN-gamma) as indicators of immunological response to surgery.
Research ethics:
The project has obtained ethics approval from The Regional Scientific Ethical Committees for Southern Denmark and acceptance to perform clinical research has been granted by The Danish Health and Medicines Authority. Consent to data collection has been provided by The Danish Data Protection Agency. Before entering the project, consent will be obtained from all patients. Rigorous data security will be maintained for five years and afterwards all data will be deleted. The Study is registered with The European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) with EudraCT number 2014-000760-18 and is monitored by The Good Clinical Practice unit for Southern Denmark.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 161 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Epidural catheter: Bupivacain 1,0 mg/ml + Fentanyl 2 micrograms/ml. Oral analgesia: Paracetamol, NSAID and placebo tablets.
Drug: Bupivacaine in epidural catheter · Drug: Fentanyl in epidural catheter · Drug: Oral Paracetamol · Drug: Oral NSAID · Drug: Placebo (for oral opioids)
Epidural analgesia: Placebo. Oral analgesia: Paracetamol, NSAID and opioids tablets.
Drug: Placebo (for Bupivacain and Fentanyl i epidural catheter) · Drug: Oral Paracetamol · Drug: Oral NSAID · Drug: Oral opioids
Bupivacain to be given in epidural catheter
Fentanyl to be given in epidural catheter
Saline to be given in epidural catheter
Paracetamol to be given orally
NSAID to be given orally
Opioids to be given orally
Placebo tablets to be given instead of oral opioids
Intensity of pain (Self reported pain intensity)
Self reported pain intensity 5 times a day both in rest and during activity until chest tube is removed or day 4 after operation is reached.
Time frame: 0-4 days
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.
Time frame: 0-4 days
Duration of surgery
The duration of the surgical procedure will be registered.
Time frame: 0-4 days
Length of hospital stay
Admission time after surgery.
Time frame: 0-4 days
Time used placing epidural catheter
Procedural time and competence level of MD placing catheter
Time frame: 0-4 days
Side effects of epidural analgesia
Side effects observed using epidural analgesia including itching, nausea, vomiting, procedural pain, hypotension, dizziness, respiratory depression, reduced pulmonary function.
Time frame: 0-4 days
Sequelae following VATS and placement of epidural catheter
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).
Time frame: 60 months
Immune cells - NK cell levels.
Levels of NK-cells will be examined as an indicator of immunological response to surgery. (The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells - NK cell levels" as primary outcome measure and "Immune cells - NK cell activity", Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part of the study. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.)
Time frame: During surgery and one hour and 24 hours after surgery, and compared with pre-operative levels.
Immune cells - NK cell activity.
The NK-cell activity will be examined as an indicator of immunological response to surgery. (The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells - NK cell levels" as primary outcome measure and "Immune cells - NK cell activity", Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part of the study. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.)
Time frame: During surgery and one hour and 24 hours after surgery, and compared with pre-operative levels.
Cytokines
Levels of cytokines (IL-6, IL-10, IL-12 and IFN-gamma) will be examined as indicators of immunological response to surgery. (The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells - NK cell levels" as primary outcome measure and "Immune cells - NK cell activity", Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part of the study. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.)
Time frame: During surgery and one hour and 24 hours after surgery, and compared with pre-operative levels.
Survival after VATS
Postoperative survival analysis. (The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells" as primary outcome measure and "Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.) (text initially added October 27th 2021, as the text was by mistake no included in the update after the protocol amendment 27 July 2016)
Time frame: 60 months
Plan to share: No
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Odense University Hospital