Erector Spinae Plane Block in Uniportal VATS

Study Overview
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Brief Summary
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The main aim of this study is to compare the effectiveness of three alternative techniques (continuous Erectus Spinae Plane Block : c-ESPB; continuous Serratus Anterior Plane Block : c-SAPB; and Intercostal Nerve Block: ICNB) in reducing the severity of early postoperative pain after Uniportal-VATS lung resections. Primary outcomes will be opioid and other analgesic drugs consumption in the 72 hours after surgery, and static and dynamic pain scores, measured by the visual analog scale (VAS), at 6 pre-established time-points during the first 48 hours postoperatively. Further outcomes will be incidence of pulmonary and cardiac complications until patient's discharging, pain when removing drains, presence/absence of chronic neuropathic pain (12 weeks after surgery).

Detailed Description
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Patients will be enrolled into three groups: continuous Erector Spinae Plane Block group (c-ESPB group) continuous Serratus Anterior Plane Block group (c-SAPB group) Intercostal Nerve Block group (ICNB group) In the c-ESPB group an ultrasound-guided ESPB will be performed by the attending anaesthesiologist at the end of surgery, immediately after the last surgical stitch and before extubation. After an initial bolus of 20 ml 0,2% ropivacaine, a catheter will be left into the fascial plane deep to the erector spinae muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic. In the c-SAPB group SAPB will be performed by surgeons intraoperatively, immediately after chest wall disclosure, by injection of 20 ml 0,2% ropivacaine into the fascial plane deep to the Serratus Anterior muscle. After the initial bolus, a catheter will be left into the fascial plane deep to the Serratus Anterior muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic. In the ICNB-group ICNB will be performed by surgeons intraoperatively, immediately after drain placement, by injection of 20 ml of 0,2% ropivacaine from within the chest under direct visualization of the intercostal spaces. The one-shot ICNB will be associated in this group with intravenous administration of tramadol (300 mg/48 h) by elastomeric pump. The enrollment of patients into a specific group will depend on surgical variables (like disruption or not of serratus muscle/intercostal fascial planes), availability of an operator (surgeon/anesthesiologist) skilled in performing peripheral nerve blocks, logistic variables (availability of materials and ultrasound equipment). The above mentioned primary/secondary outcome measures will be evaluated in each group and compared among them.

Official Title
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Effectiveness of Erector Spinae Plane Block in Uniportal VATS Lung Resections

Conditions
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Thoracic Surgery, Uniportal Video Assisted Thoracic Surgery (U-VATS), Lung Resections, Post-Operative Pain, Chronic, Acute Pain, Post-operative Complications, Locoregional Anesthesia

Intervention / Treatment
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* Procedure: c-ESPB
* Procedure: c-SAPB
* Procedure: ICNB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Age >18 years Exclusion Criteria: Patients who will not sign the informed consent. Patients scheduled for open thoracic surgery or not undergoing Uniportal-VATS resections. Patients undergoing concomitant chest wall, diaphragm resection or mechanical/chemical pleurodesis. History of previous thoracic surgery. Patients with Chronic Post-Thoracotomy Pain. Rib cage deformity or scoliosis. Inherited or acquired coagulopathies. History of allergy to drugs used during the study. Age < 18 years. Patients suffering from psychiatric or neurodegenerative diseases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| c-ESPB group<br>Postoperative analgesia ensured by continuous ultrasound-guided ESPB performed at the end of surgery. | Procedure: c-ESPB<br>* In the c-ESPB group an ultrasound-guided ESPB will be performed by the attending anaesthesiologist at the end of surgery, immediately after the last surgical stitch and before extubation. After an initial bolus of 20 ml 0,2% ropivacaine, a catheter will be left in place into the fascial plane deep to the erector spinae muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.<br>|
| c-SAPB group<br>Postoperative analgesia ensured by continuous SAPB performed by surgeons at the end of surgery. | Procedure: c-SAPB<br>* In the c-SAPB group SAPB will be performed by surgeons intraoperatively, immediately before the closure of chest wall muscle planes, by injection of 20 ml 0,2% ropivacaine into the fascial plane above the Serratus Anterior muscle. After the initial bolus, a catheter will be left in place into the superficial fascial plane of the Serratus Anterior muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.<br>|
| ICNB-group<br>Postoperative analgesia ensured by one-shot ICNB + continuous intravenous administration of tramadol by elastomeric pump. | Procedure: ICNB<br>* In the ICNB-group ICNB will be performed by surgeons intraoperatively, immediately before chest drain placement, by injection of 20 ml of 0,2% ropivacaine into the intercostal spaces (III-VII), below the parietal pleura, under direct visualization of the neurovascular bundle. The one-shot ICNB will be associated in this group with intravenous administration of tramadol (300 mg/48 h) by elastomeric pump.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic drug consumption | number of doses of analgesic drugs administered on patients' request during the postoperative period | first 72 hours after extubation | 
| severity of early postoperative pain | static and dynamic pain scores, measured by the visual analog scale (VAS), at 6 pre-established time-points during the first 48 hours postoperatively. | first 48 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory and cardiac complications | Incidence of post-operative respiratory complications (i.e. atelectasis, pneumonia, arrhythmias, etc) | first 72 hours after extubation | 
| pain at drain removal | severity of pain, measured by the visual analog scale (VAS), at chest drain removal | chest drain removal (third/fourth postoperative day) | 
| incidence of chronic pain | presence of chronic neuropathic pain after surgery | 12 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESPB, Erectus Spinae Plane Block, SAPB, Serratus Anterior Plane Block, ICNB, Intercostal Block, Uniportal VATS, Thoracic Surgery