NCT02359175

Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * Have a epidural catheter placed. * Receive a basis level of analgesics consisting of paracetamol and a nonsteroidal anti- inflammatory drug combined with a nerveblock placed intercostally during surgery. * Have access to i.v. opioids as needed for any experienced pain after surgery. 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.

Conditions

• Lung Neoplasms
• Pain
• Immune Suppression

Interventions

Type	Name	Description
DRUG	Bupivacaine in epidural catheter	Bupivacain to be given in epidural catheter
DRUG	Fentanyl in epidural catheter	Fentanyl to be given in epidural catheter
DRUG	Placebo (for Bupivacain and Fentanyl i epidural catheter)	Saline to be given in epidural catheter
DRUG	Oral Paracetamol	Paracetamol to be given orally
DRUG	Oral NSAID	NSAID to be given orally
DRUG	Oral opioids	Opioids to be given orally
DRUG	Placebo (for oral opioids)	Placebo tablets to be given instead of oral opioids

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-01-24
• Completion: 2023-03-22
• First posted: 2015-02-09
• Last updated: 2023-06-27

Locations

1 site across 1 country: Denmark