search
Back to results

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

Primary Purpose

Pain, Postoperative, Post-Op Complication

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Erector spinae plane block with ropivacaine 3.75mg/ml
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    PCIA arm

    ESP block arm

    IC block arm

    Arm Description

    Standard post-operative treatment with patient-controlled intravenous analgesia (Piritramide bolus = 2mg, bolus interval = 7 minutes, max 4 hour dose = 30mg)

    ultrasound guided Erector spinae block (Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine])

    3 ml of 0.5% solution of Naropin [Ropivacaine] per intercostal space, up to a maximum of 30ml

    Outcomes

    Primary Outcome Measures

    Efficacy of ESP block in decreasing postoperative pain intensity
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 19, 2020
    Last Updated
    May 26, 2020
    Sponsor
    Universitair Ziekenhuis Brussel
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04400721
    Brief Title
    Efficacy of an Erector Spinae Plane Block in VATS/RATS
    Acronym
    ESPAM
    Official Title
    The Effects of Thoracic Nerve Blocks on Postoperative Pain, Respiratory Function and Recovery in Patients Undergoing Thoracoscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    June 28, 2022 (Anticipated)
    Study Completion Date
    February 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitair Ziekenhuis Brussel

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Post-Op Complication

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Single-blinded, single-center, randomized, prospective study
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PCIA arm
    Arm Type
    No Intervention
    Arm Description
    Standard post-operative treatment with patient-controlled intravenous analgesia (Piritramide bolus = 2mg, bolus interval = 7 minutes, max 4 hour dose = 30mg)
    Arm Title
    ESP block arm
    Arm Type
    Active Comparator
    Arm Description
    ultrasound guided Erector spinae block (Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine])
    Arm Title
    IC block arm
    Arm Type
    Active Comparator
    Arm Description
    3 ml of 0.5% solution of Naropin [Ropivacaine] per intercostal space, up to a maximum of 30ml
    Intervention Type
    Drug
    Intervention Name(s)
    Erector spinae plane block with ropivacaine 3.75mg/ml
    Other Intervention Name(s)
    Naropin
    Intervention Description
    Single shot erector spinae block
    Primary Outcome Measure Information:
    Title
    Efficacy of ESP block in decreasing postoperative pain intensity
    Description
    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
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Domien Vanhonacker, MD
    Phone
    +32494652763
    Email
    domienvanhonacker@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yanina Jansen, MD
    Phone
    +3247589116
    Email
    yanina.jansen@uzbrussel.be

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of an Erector Spinae Plane Block in VATS/RATS

    We'll reach out to this number within 24 hrs