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Efficacy of an Erector Spinae Plane Block in VATS/RATS (ESPAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400721
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Brief Summary:
This study aims to study the analgesic and respiratory effects of the erector spinae plane block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted thoracic surgery (RATS).

Condition or disease Intervention/treatment Phase
Pain, Postoperative Post-Op Complication Drug: Erector spinae plane block with ropivacaine 3.75mg/ml Phase 3

Detailed Description:

A total of 120 subjects will be randomized into three groups (30 per group). Arm A: IV PCIA Arm B: IV PCIA + ultrasound guided Erector spinae block (ESPB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) Arm C: IV PCIA + multilevel intra-thoracic intercostal nerve block (ICB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) PCIA pumps for all study cohorts will be programmed according to our institution's standard protocol (Dipidolor [Piritramide] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). The erector spinae block will be placed preoperatively, the intercostal block will be placed at the beginning of the procedure. All patients will receive standard postoperative care. The patients will be blinded for the study arm.

The primary endpoint of this study is postoperative pain and will be recorded by using the numerical rating scale (NRS) pain score. Pain scores will be measured by the investigator at rest and during coughing. Opioid consumption will be monitored and registered for.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-blinded, single-center, randomized, prospective study
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effects of Thoracic Nerve Blocks on Postoperative Pain, Respiratory Function and Recovery in Patients Undergoing Thoracoscopic Surgery
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 28, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: PCIA arm
Standard post-operative treatment with patient-controlled intravenous analgesia (Piritramide bolus = 2mg, bolus interval = 7 minutes, max 4 hour dose = 30mg)
Active Comparator: ESP block arm
ultrasound guided Erector spinae block (Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine])
Drug: Erector spinae plane block with ropivacaine 3.75mg/ml
Single shot erector spinae block
Other Name: Naropin

Active Comparator: IC block arm
3 ml of 0.5% solution of Naropin [Ropivacaine] per intercostal space, up to a maximum of 30ml
Drug: Erector spinae plane block with ropivacaine 3.75mg/ml
Single shot erector spinae block
Other Name: Naropin




Primary Outcome Measures :
  1. Efficacy of ESP block in decreasing postoperative pain intensity [ Time Frame: 48 hours ]
    Pain levels will be assessed using the 10 points Visual analogue Scale (VAS) where zero= no pain and 10= pain as bad as it can be. The vaS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients
  • age between 18 to 100 years old
  • ASA 1-3
  • scheduled for VATS
  • informed consent explained and signed

Exclusion Criteria:

  • Patients < 18 years old, > 100 years old
  • ASA physical status > 3
  • previous cardiac surgery or ipsilateral thoracic surgery
  • neuropsychiatric diseases
  • allergy to analgesics or local anesthetics or other medications used in the study
  • abuse of opioids or sedatives
  • contraindication to receive regional anesthesia (e.g. coagulation defect)
  • patients who could not understand the VAS pain-scoring system
  • patient refusal to follow participation
  • expected post operative mechanical ventilation
  • intolerance or allergy to any prescribed medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400721


Contacts
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Contact: Domien Vanhonacker, MD +32494652763 domienvanhonacker@gmail.com
Contact: Yanina Jansen, MD +3247589116 yanina.jansen@uzbrussel.be

Sponsors and Collaborators
Universitair Ziekenhuis Brussel
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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04400721    
Other Study ID Numbers: UZB-VUB-19-01
2019-003534-17 ( EudraCT Number )
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents