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

NCT02359175 | Completed Phase 4 DMC

• 1 other identifier: 13.034
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms; Pain; Immune Suppression

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

Outcome Measures

Primary Outcomes (2)

• 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.

  0-4 days

• 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.

  0-4 days

Secondary Outcomes (5)

• Duration of surgery

  0-4 days

• Length of hospital stay

  0-4 days

• Time used placing epidural catheter

  0-4 days

• Side effects of epidural analgesia

  0-4 days

• Sequelae following VATS and placement of epidural catheter

  60 months

Other Outcomes (4)

• Immune cells - NK cell levels.

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

• Immune cells - NK cell activity.

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

• Cytokines

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

Study Arms (2)

Active Epidural analgesia

ACTIVE COMPARATOR

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

Drug: Bupivacaine in epidural catheter; Drug: Fentanyl in epidural catheter; Drug: Oral Paracetamol; Drug: Oral NSAID; Drug: Placebo (for oral opioids)

Placebo Epidural analgesia

ACTIVE COMPARATOR

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

Drug: Placebo (for Bupivacain and Fentanyl i epidural catheter); Drug: Oral Paracetamol; Drug: Oral NSAID; Drug: Oral opioids

Interventions

Bupivacaine in epidural catheter DRUG

Bupivacain to be given in epidural catheter

Active Epidural analgesia

Fentanyl in epidural catheter DRUG

Fentanyl to be given in epidural catheter

Active Epidural analgesia

Placebo (for Bupivacain and Fentanyl i epidural catheter) DRUG

Saline to be given in epidural catheter

Placebo Epidural analgesia

Oral Paracetamol DRUG

Paracetamol to be given orally

Active Epidural analgesia; Placebo Epidural analgesia

Oral NSAID DRUG

NSAID to be given orally

Active Epidural analgesia; Placebo Epidural analgesia

Oral opioids DRUG

Opioids to be given orally

Placebo Epidural analgesia

Placebo (for oral opioids) DRUG

Placebo tablets to be given instead of oral opioids

Active Epidural analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

Related Publications (8)

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

  PMID: 16549628 BACKGROUND

• 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.

  PMID: 19794994 BACKGROUND

• 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.

  PMID: 22058144 BACKGROUND

• 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.

  PMID: 23026166 BACKGROUND

• 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.

  PMID: 17095972 BACKGROUND

• 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.

  PMID: 15784372 BACKGROUND

• 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.

  PMID: 39323258 DERIVED

• 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.

  PMID: 37962202 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Pain

Interventions

Bupivacaine; Fentanyl; Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Narcotics; Central Nervous System Depressants; Central Nervous System Agents

Study Officials

• Jimmy H Holm, MD

  Department of Anaesthesia and Intensive Care - Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 9, 2015
• Study Start: February 1, 2015
• Primary Completion: January 24, 2019
• Study Completion: March 22, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)