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

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.

Conditions

• Lung Neoplasms
• Pain
• Immune Suppression

Interventions

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

Sponsors & Collaborators

• Odense University Hospital

  lead OTHER

Principal Investigators

• Jimmy H Holm, MD · Department of Anaesthesia and Intensive Care - Odense University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2019-01-24

Completion

2023-03-22

Countries

• Denmark

Study Locations