Clinical trial · Interventional
Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immune Suppression | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine in epidural catheter | Drug | — | UNRESOLVED |
| Fentanyl in epidural catheter | Drug | — | UNRESOLVED |
| Oral NSAID | Drug | — | UNRESOLVED |
| Oral opioids | Drug | — | UNRESOLVED |
| Oral Paracetamol | Drug | — | UNRESOLVED |
| Placebo (for Bupivacain and Fentanyl i epidural catheter) | Drug | — | UNRESOLVED |
| Placebo (for oral opioids) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active Epidural analgesia
- description
- Epidural catheter: Bupivacain 1,0 mg/ml + Fentanyl 2 micrograms/ml. Oral analgesia: Paracetamol, NSAID and placebo tablets.
- interventionNames
- Drug: Bupivacaine in epidural catheter
- Drug: Fentanyl in epidural catheter
- Drug: Oral Paracetamol
- Drug: Oral NSAID
- Drug: Placebo (for oral opioids)
- type
- ACTIVE_COMPARATOR
- label
- Placebo Epidural analgesia
- description
- Epidural analgesia: Placebo. Oral analgesia: Paracetamol, NSAID and opioids tablets.
- interventionNames
- Drug: Placebo (for Bupivacain and Fentanyl i epidural catheter)
- Drug: Oral Paracetamol
- Drug: Oral NSAID
- Drug: Oral opioids
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. 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)
References
Publications (8)
- BACKGROUNDRichardson J, Cheema S. Thoracic paravertebral nerve block. Br J Anaesth. 2006 Apr;96(4):537. doi: 10.1093/bja/ael038. No abstract available. PMID 16549628
- BACKGROUNDKim JA, Kim TH, Yang M, Gwak MS, Kim GS, Kim MJ, Cho HS, Sim WS. Is intravenous patient controlled analgesia enough for pain control in patients who underwent thoracoscopy? J Korean Med Sci. 2009 Oct;24(5):930-5. doi: 10.3346/jkms.2009.24.5.930. Epub 2009 Sep 23. PMID 19794994
- BACKGROUNDFreise H, Van Aken HK. Risks and benefits of thoracic epidural anaesthesia. Br J Anaesth. 2011 Dec;107(6):859-68. doi: 10.1093/bja/aer339. Epub 2011 Nov 4. PMID 22058144
- BACKGROUNDYie JC, Yang JT, Wu CY, Sun WZ, Cheng YJ. Patient-controlled analgesia (PCA) following video-assisted thoracoscopic lobectomy: comparison of epidural PCA and intravenous PCA. Acta Anaesthesiol Taiwan. 2012 Sep;50(3):92-5. doi: 10.1016/j.aat.2012.08.004. Epub 2012 Sep 7. PMID 23026166
- BACKGROUNDYoshioka M, Mori T, Kobayashi H, Iwatani K, Yoshimoto K, Terasaki H, Nomori H. The efficacy of epidural analgesia after video-assisted thoracoscopic surgery: a randomized control study. Ann Thorac Cardiovasc Surg. 2006 Oct;12(5):313-8. PMID 17095972
- BACKGROUNDFernandez MI, Martin-Ucar AE, Lee HD, West KJ, Wyatt R, Waller DA. Does a thoracic epidural confer any additional benefit following video-assisted thoracoscopic pleurectomy for primary spontaneous pneumothorax? Eur J Cardiothorac Surg. 2005 Apr;27(4):671-4. doi: 10.1016/j.ejcts.2004.12.045. PMID 15784372
- DERIVEDHolm JH, Andersen C, Licht PB, Toft P, Zegers FD, Lambertsen KL, Brochner AC. Immunological effects of post-operative epidural analgesia versus oral opioids in VATS. Dan Med J. 2024 Sep 9;71(10):A09230582. doi: 10.61409/A09230582.