ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery

Study Overview
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Brief Summary
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A randomized prospective trial to test the non-inferiority of erector spinae plane block (ESPB) in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in Thoracoscopic lung surgery

Detailed Description
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For patients undergoing thoracic surgery, postoperative pain greatly limited their recovery.Multimodal analgesia have shown good efficacy but without reaching full pain relief. The primary goal of this study is to observe the effect of ultrasound-guided erector spinae plane block in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in video assisted thoracic lung surgery.

Official Title
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Erector Spinae Plane Block Versus Intercostal Nerve Block Combined With Patient-controlled Intravenous Analgesia in Video-assisted Thoracic Surgery

Conditions
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Lung Diseases

Intervention / Treatment
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* Drug: Intercostal Nerve Block with PCIA
* Drug: Erector Spinae Plane Block (ESPB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients to receive video assisted thoracoscopic lobectomy or bullectomy . Exclusion Criteria: 1. Patient refusal 2. Heavy skin eruption and infection at site of injection. 3. Coagulopathy. 4. Allergy to local anesthetics. 5. Taking analgesics.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intercostal Nerve Block with PCIA<br>Intercostal Nerve Block with patient-controlled intravenous analgesia | Drug: Intercostal Nerve Block with PCIA<br>* Intercostal nerve block consists in the injection of Ropivacaine (4 ml,0.5%) in related intercostal spaces. Patient-controlled intravenous analgesia regimen is conducted with sufentanil.<br>|
| Experimental: Erector Spinae Plane Block (ESPB)<br>Continuous Erector Spinae Plane Block | Drug: Erector Spinae Plane Block (ESPB)<br>* Erector Spinae Plane Block consists in the injection of Ropivacaine (20ml, 0.5%), in the anatomical plane between the Erector Spinae muscles and transverse process, laterally to the spinous process of T5 . The catheter was inserted and secured in place under ecographic guidance, and a patient-controlled regional anesthesia regimen was conducted with 0.2% ropivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (NRS) | Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome. | 4 hours from the end of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (NRS) | Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome. | 8, 24,48 hours from the end of procedure | 
| Analgesics consumption | Analgesics include opioids and nonsteroidal anti-inflammatory drugs | During operation,4, 8, 24,48 hours from the end of procedure | 
| Incidence of side effects and complication during study | Side effects and complication | During operation,4, 8, 24,48 hours from the end of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector spinae plane block, Video-assisted thoracic surgery;, Intercostal nerve block, Patient-controlled intravenous analgesia