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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04400721
Collaborator
(none)
120
Enrollment
3
Arms
31
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-blinded, single-center, randomized, prospective studySingle-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
Anticipated Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Jun 28, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • Naropin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of ESP block in decreasing postoperative pain intensity [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Universitair Ziekenhuis Brussel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitair Ziekenhuis Brussel
    ClinicalTrials.gov Identifier:
    NCT04400721
    Other Study ID Numbers:
    • UZB-VUB-19-01
    • 2019-003534-17
    First Posted:
    May 22, 2020
    Last Update Posted:
    May 28, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Pain, Postoperative
    Postoperative Complications
    Ropivacaine

    Study Results

    No Results Posted as of May 28, 2020