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
About this trial
This is an interventional supportive care trial for Pain, Postoperative
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
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
NCT ID
NCT04400721
First Posted
May 19, 2020
Last Updated
May 26, 2020
Sponsor
Universitair Ziekenhuis Brussel
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
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