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

• Status: Active, not recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Treatments: Acetaminophen; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Bupivacaine; Fentanyl

Criteria

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)