Efficacy of an Erector Spinae Plane Block in VATS/RATS

Phase 3

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

• Registration Number: NCT04400721
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28
• Study Start: 2020-07-01
• Primary Completion: 2022-06-28
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP block arm	Erector spinae plane block with ropivacaine 3.75mg/ml	ultrasound guided Erector spinae block (Single shot of 30ml of 0.5% solution of Naropin \[Ropivacaine\])
IC block arm	Erector spinae plane block with ropivacaine 3.75mg/ml	3 ml of 0.5% solution of Naropin \[Ropivacaine\] per intercostal space, up to a maximum of 30ml

Primary Outcome Measures

Name	Time	Method
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