At a glance
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Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study
In Brief
A Phase 4 clinical trial evaluating Bupivacaine in epidural catheter, Fentanyl in epidural catheter, and 5 other interventions for Lung Neoplasms and 2 related conditions. Completed, enrolled 161 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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