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

NCT ID: NCT02359175

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2023-03-22

Brief 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.

Detailed Description

Study plan:

The hypothesis is that there is no difference in the amount of pain the patients will experience after VATS for pulmonary neoplasms.

Study design and setting:

The project is designed as a prospectively, double blinded, randomized, placebo controlled study comparing pain in two groups of patients.

Both groups of patients will:

• Have a epidural catheter placed.
• Receive a basis level of analgesics consisting of paracetamol and a nonsteroidal anti- inflammatory drug combined with a nerveblock placed intercostally during surgery.
• Have access to i.v. opioids as needed for any experienced pain after surgery.

One group of patients will be given local anaesthetics through the epidural catheter supplemented with placebo medication orally while the other group will receive saline in the epidural catheter supplemented with opioids orally.

Data collection:

Data will, during hospitalization, be collected in the operating theatre, in the postoperative care unit and in the surgical ward. Six months after surgery a questionnaire will be send to the patients to do follow-up regarding residual sequelae after surgery and placement of epidural catheter. Further follow-up with questionnaire has been planned for subsequent years.

As a secondary objective, in fifty-six of the patients from The SEAVATS Study, blood samples will be gathered during surgery and one hour and 24 hours after surgery, and compared with pre-operative levels.

These blood samples will be analysed for immune cells (NK-cells, levels and activity) and cytokines (IL-6, IL-10, IL-12 and IFN-gamma) as indicators of immunological response to surgery.

Research ethics:

The project has obtained ethics approval from The Regional Scientific Ethical Committees for Southern Denmark and acceptance to perform clinical research has been granted by The Danish Health and Medicines Authority. Consent to data collection has been provided by The Danish Data Protection Agency. Before entering the project, consent will be obtained from all patients. Rigorous data security will be maintained for five years and afterwards all data will be deleted. The Study is registered with The European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) with EudraCT number 2014-000760-18 and is monitored by The Good Clinical Practice unit for Southern Denmark.

Conditions

Lung Neoplasms; Pain; Immune Suppression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Epidural analgesia

Epidural catheter: Bupivacain 1,0 mg/ml + Fentanyl 2 micrograms/ml. Oral analgesia: Paracetamol, NSAID and placebo tablets.

Group Type: ACTIVE_COMPARATOR

Bupivacaine in epidural catheter

Intervention Type: DRUG

Bupivacain to be given in epidural catheter

Fentanyl in epidural catheter

Intervention Type: DRUG

Fentanyl to be given in epidural catheter

Oral Paracetamol

Intervention Type: DRUG

Paracetamol to be given orally

Oral NSAID

Intervention Type: DRUG

NSAID to be given orally

Placebo (for oral opioids)

Intervention Type: DRUG

Placebo tablets to be given instead of oral opioids

Placebo Epidural analgesia

Epidural analgesia: Placebo. Oral analgesia: Paracetamol, NSAID and opioids tablets.

Group Type: ACTIVE_COMPARATOR

Placebo (for Bupivacain and Fentanyl i epidural catheter)

Intervention Type: DRUG

Saline to be given in epidural catheter

Oral Paracetamol

Intervention Type: DRUG

Paracetamol to be given orally

Oral NSAID

Intervention Type: DRUG

NSAID to be given orally

Oral opioids

Intervention Type: DRUG

Opioids to be given orally

Interventions

Bupivacaine in epidural catheter

Bupivacain to be given in epidural catheter

Intervention Type: DRUG

Fentanyl in epidural catheter

Fentanyl to be given in epidural catheter

Intervention Type: DRUG

Placebo (for Bupivacain and Fentanyl i epidural catheter)

Saline to be given in epidural catheter

Intervention Type: DRUG

Oral Paracetamol

Paracetamol to be given orally

Intervention Type: DRUG

Oral NSAID

NSAID to be given orally

Intervention Type: DRUG

Oral opioids

Opioids to be given orally

Intervention Type: DRUG

Placebo (for oral opioids)

Placebo tablets to be given instead of oral opioids

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jimmy Højberg Holm

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jimmy H Holm, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia and Intensive Care - Odense University Hospital

Locations

Odense University Hospital

Odense C, , Denmark

Countries

Denmark

References

Richardson J, Cheema S. Thoracic paravertebral nerve block. Br J Anaesth. 2006 Apr;96(4):537. doi: 10.1093/bja/ael038. No abstract available.

Reference Type: BACKGROUND

PMID: 16549628 (View on PubMed)

Kim JA, Kim TH, Yang M, Gwak MS, Kim GS, Kim MJ, Cho HS, Sim WS. Is intravenous patient controlled analgesia enough for pain control in patients who underwent thoracoscopy? J Korean Med Sci. 2009 Oct;24(5):930-5. doi: 10.3346/jkms.2009.24.5.930. Epub 2009 Sep 23.

Reference Type: BACKGROUND

PMID: 19794994 (View on PubMed)

Freise H, Van Aken HK. Risks and benefits of thoracic epidural anaesthesia. Br J Anaesth. 2011 Dec;107(6):859-68. doi: 10.1093/bja/aer339. Epub 2011 Nov 4.

Reference Type: BACKGROUND

PMID: 22058144 (View on PubMed)

Yie JC, Yang JT, Wu CY, Sun WZ, Cheng YJ. Patient-controlled analgesia (PCA) following video-assisted thoracoscopic lobectomy: comparison of epidural PCA and intravenous PCA. Acta Anaesthesiol Taiwan. 2012 Sep;50(3):92-5. doi: 10.1016/j.aat.2012.08.004. Epub 2012 Sep 7.

Reference Type: BACKGROUND

PMID: 23026166 (View on PubMed)

Yoshioka M, Mori T, Kobayashi H, Iwatani K, Yoshimoto K, Terasaki H, Nomori H. The efficacy of epidural analgesia after video-assisted thoracoscopic surgery: a randomized control study. Ann Thorac Cardiovasc Surg. 2006 Oct;12(5):313-8.

Reference Type: BACKGROUND

PMID: 17095972 (View on PubMed)

Fernandez MI, Martin-Ucar AE, Lee HD, West KJ, Wyatt R, Waller DA. Does a thoracic epidural confer any additional benefit following video-assisted thoracoscopic pleurectomy for primary spontaneous pneumothorax? Eur J Cardiothorac Surg. 2005 Apr;27(4):671-4. doi: 10.1016/j.ejcts.2004.12.045.

Reference Type: BACKGROUND

PMID: 15784372 (View on PubMed)

Holm JH, Andersen C, Licht PB, Toft P, Zegers FD, Lambertsen KL, Brochner AC. Immunological effects of post-operative epidural analgesia versus oral opioids in VATS. Dan Med J. 2024 Sep 9;71(10):A09230582. doi: 10.61409/A09230582.

Reference Type: DERIVED

PMID: 39323258 (View on PubMed)

Holm JH, Andersen C, Toft P. Epidural analgesia versus oral morphine for postoperative pain management following video-assisted thoracic surgery: A randomised, controlled, double-blind trial. Eur J Anaesthesiol. 2024 Jan 1;41(1):61-69. doi: 10.1097/EJA.0000000000001921. Epub 2023 Nov 15.

Reference Type: DERIVED

PMID: 37962202 (View on PubMed)

Other Identifiers

13.034

Identifier Type: -

Identifier Source: org_study_id