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

Sponsor
Odense University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02359175
Collaborator
(none)
124
1
2
112
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine in epidural catheter
  • Drug: Fentanyl in epidural catheter
  • Drug: Placebo (for Bupivacain and Fentanyl i epidural catheter)
  • Drug: Oral Paracetamol
  • Drug: Oral NSAID
  • Drug: Oral opioids
  • Drug: Placebo (for oral opioids)
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study
Actual Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Jan 24, 2019
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active Epidural analgesia

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

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: Oral Paracetamol
Paracetamol to be given orally

Drug: Oral NSAID
NSAID to be given orally

Drug: Placebo (for oral opioids)
Placebo tablets to be given instead of oral opioids

Active Comparator: Placebo Epidural analgesia

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

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

Outcome Measures

Primary Outcome Measures

  1. Intensity of pain (Self reported pain intensity) [0-4 days]

    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.

  2. Consumption "Rescue Analgesia" - i.v. opioids [0-4 days]

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

Secondary Outcome Measures

  1. Duration of surgery [0-4 days]

    The duration of the surgical procedure will be registered.

  2. Length of hospital stay [0-4 days]

    Admission time after surgery.

  3. Time used placing epidural catheter [0-4 days]

    Procedural time and competence level of MD placing catheter

  4. Side effects of epidural analgesia [0-4 days]

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

  5. Sequelae following VATS and placement of epidural catheter [60 months]

    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).

Other Outcome Measures

  1. Immune cells - NK cell levels. [During surgery and one hour and 24 hours after surgery, and compared with pre-operative levels.]

    Levels of NK-cells will be examined as an indicator of immunological response to surgery. (The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells - NK cell levels" as primary outcome measure and "Immune cells - NK cell activity", Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part of the study. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.)

  2. Immune cells - NK cell activity. [During surgery and one hour and 24 hours after surgery, and compared with pre-operative levels.]

    The NK-cell activity will be examined as an indicator of immunological response to surgery. (The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells - NK cell levels" as primary outcome measure and "Immune cells - NK cell activity", Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part of the study. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.)

  3. Cytokines [During surgery and one hour and 24 hours after surgery, and compared with pre-operative levels.]

    Levels of cytokines (IL-6, IL-10, IL-12 and IFN-gamma) will be examined as indicators of immunological response to surgery. (The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells - NK cell levels" as primary outcome measure and "Immune cells - NK cell activity", Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part of the study. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.)

  4. Survival after VATS [60 months]

    Postoperative survival analysis. (The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells" as primary outcome measure and "Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.) (text initially added October 27th 2021, as the text was by mistake no included in the update after the protocol amendment 27 July 2016)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Odense University Hospital Odense C Denmark 5000

Sponsors and Collaborators

  • Odense University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jimmy Højberg Holm, MD, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT02359175
Other Study ID Numbers:
  • 13.034
First Posted:
Feb 9, 2015
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Jimmy Højberg Holm, MD, Odense University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2022