CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 161 enrolled
Drug / intervention
Bupivacaine in epidural catheter +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02359175
NCT02359175Phase 4Completed

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

Odense University Hospital·interventional·Posted Feb 9, 2015·Updated Jun 27, 2023

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 9, 2015
Enrollment StartFeb 1, 2015
Primary CompletionJan 24, 2019
Study CompletionMar 22, 2023
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 11.4 years ago

Interventions

Bupivacaine in epidural catheterdrug

Bupivacain to be given in epidural catheter

Fentanyl in epidural catheterdrug

Fentanyl to be given in epidural catheter

Placebo (for Bupivacain and Fentanyl i epidural catheter)drug

Saline to be given in epidural catheter

Oral Paracetamoldrug

Paracetamol to be given orally

Oral NSAIDdrug

NSAID to be given orally

Oral opioidsdrug

Opioids to be given orally

Placebo (for oral opioids)drug

Placebo tablets to be given instead of oral opioids