drugset / Trial / NCT02359175

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

NCT02359175 ↗

Phase 4 Completed 161 enrolled Odense University Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-02
Primary completion
2019-01-24
Completion
2023-03-22

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 1 mg/ml Other
Comparator Fentanyl Other / unclassified 2 ug/ml Other
Comparator Morphine Other / unclassified — Oral
Comparator Acetaminophen Small molecule — Oral

Indications