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Lung NeoplasmsPhase 4SEAVATSNCT02359175

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

A Phase 4 study testing Bupivacaine in epidural catheter, Fentanyl in epidural catheter and Oral Paracetamol in people with Lung Neoplasms and Pain, run by Odense University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Neoplasms, Pain, Immune Suppression
What is being tested?
Bupivacaine in epidural catheter, Fentanyl in epidural catheter and Oral Paracetamol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
161 participants
Where
1 siteDenmark
Study dates
Feb 2015to 22 Mar 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Odense University Hospital

    Odense C, 5000

Other trials in Denmark

About this study

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.

Read more

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.

Read the 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.

Being tested
Bupivacaine in epidural catheter, Fentanyl in epidural catheter, Placebo (for Bupivacain and Fentanyl i epidural catheter), Oral Paracetamol, Oral NSAID
Keywords
Pain, Pain Measurement, VAS, Visual Analog Pain Scale, Analgesics, Opioid, Epidural analgesia, VATS, Video-assisted Thoracic Surgery, Lobectomy, Wedge Resection, Segmental Resection, Cytokins, Immune cells
Medical subject headings
Lung Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT02359175
Study groupRoleWhat they receive
Active Epidural analgesiaActive comparatorEpidural catheter: Bupivacain 1,0 mg/ml + Fentanyl 2 micrograms/ml. Oral analgesia: Paracetamol, NSAID and placebo tablets.
Receives: Drug: Bupivacaine in epidural catheter; Drug: Fentanyl in epidural catheter; Drug: Oral Paracetamol; Drug: Oral NSAID; Drug: Placebo (for oral opioids)
Placebo Epidural analgesiaActive comparatorEpidural analgesia: Placebo. Oral analgesia: Paracetamol, NSAID and opioids tablets.
Receives: Drug: Placebo (for Bupivacain and Fentanyl i epidural catheter); Drug: Oral Paracetamol; Drug: Oral NSAID; Drug: Oral opioids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intensity of pain (Self reported pain intensity)

    Self reported pain intensity 5 times a day both in rest and during activity until chest tube is removed or day 4 after operation is reached.

    Measured: 0-4 days

  2. Consumption "Rescue Analgesia" - i.v. opioids

    The consumption of i.v. opioids is registered daily until chest tube is removed or day 4 after operation is reached.

    Measured: 0-4 days

Secondary outcomes (5)
  1. Duration of surgery

    The duration of the surgical procedure will be registered.

    Measured: 0-4 days

  2. Length of hospital stay

    Admission time after surgery.

    Measured: 0-4 days

  3. Time used placing epidural catheter

    Procedural time and competence level of MD placing catheter

    Measured: 0-4 days

  4. Side effects of epidural analgesia

    Side effects observed using epidural analgesia including itching, nausea, vomiting, procedural pain, hypotension, dizziness, respiratory depression, reduced pulmonary function.

    Measured: 0-4 days

  5. Sequelae following VATS and placement of epidural catheter

    Questionnaire sent to patients 6, 12, 24 and 60 months after surgery. (criteria edited as part of a protocol amendment July 27th 2016 for a subsequent biomarkers study).

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completion24 Jan 2019
  4. Study completion22 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02359175
Sponsor's protocol ID
13.034
Acronym
SEAVATS
Status last verified
Jun 2023
First submitted
4 Feb 2015
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

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

    PubMed 16549628
  • 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.

    PubMed 19794994
  • 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.

    PubMed 22058144
  • 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.

    PubMed 23026166
  • 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.

    PubMed 17095972
  • 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.

    PubMed 15784372
  • 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.

    PubMed 39323258
  • 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.

    PubMed 37962202

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine in epidural catheter, Fentanyl in epidural catheter and Oral Paracetamol in people with Lung Neoplasms and Pain, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensity of pain (Self reported pain intensity) (time frame: 0-4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02359175, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.

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