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

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).

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Post-Op Complication
• Intervention / Treatment: Drug: Erector spinae plane block with ropivacaine 3.75mg/ml

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Domien Vanhonacker, MD; Phone Number: +32494652763; Email: domienvanhonacker@gmail.com
• Study Contact Backup: Name: Yanina Jansen, MD; Phone Number: +3247589116; Email: yanina.jansen@uzbrussel.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): June 28, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pain, Postoperative; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: UZB-VUB-19-01; 2019-003534-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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