Efficacy of an Erector Spinae Plane Block in VATS/RATS
ESPAM
The Effects of Thoracic Nerve Blocks on Postoperative Pain, Respiratory Function and Recovery in Patients Undergoing Thoracoscopic Surgery
2 other identifiers
interventional
120
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2020
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedMay 28, 2020
May 1, 2020
2 years
May 19, 2020
May 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
48 hours
Study Arms (3)
PCIA arm
NO INTERVENTIONStandard post-operative treatment with patient-controlled intravenous analgesia (Piritramide bolus = 2mg, bolus interval = 7 minutes, max 4 hour dose = 30mg)
ESP block arm
ACTIVE COMPARATORultrasound guided Erector spinae block (Single shot of 30ml of 0.5% solution of Naropin \[Ropivacaine\])
IC block arm
ACTIVE COMPARATOR3 ml of 0.5% solution of Naropin \[Ropivacaine\] per intercostal space, up to a maximum of 30ml
Interventions
Single shot erector spinae block
Eligibility Criteria
You may qualify if:
- Male and female patients
- age between 18 to 100 years old
- ASA 1-3
- scheduled for VATS
- informed consent explained and signed
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2020
First Posted
May 22, 2020
Study Start
July 1, 2020
Primary Completion
June 28, 2022
Study Completion
February 1, 2023
Last Updated
May 28, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share