Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy

Study Overview
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Brief Summary
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Thoracotomy surgery is the most painful of all surgical procedures. Inadequate postoperative pain control in these patients may cause serious morbidity related to pulmonary, cardiovascular and emotional systems. Erector Spinae Plane Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in thoracic surgery. Intravenous lidocaine exhibit analgesic activity through both the peripheral and central nervous system. Intravenous lidocaine has been shown to reduce postoperative pain intensity and accelerate postoperative recovery in many surgeries. The investigators aimed to compare the effect of lidocaine infusion and erector spinae plane block on postoperative opioid consumption and pain scores.

Official Title
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Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Postoperative Pain Control in Patients Undergoing Thoracotomy: A Prospective, Randomized, Double-blind Controlled Clinical Trial

Conditions
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Thoracic Diseases

Intervention / Treatment
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* Drug: Bupivacaine Hcl 0.25% Inj
* Drug: Saline Solution for Block
* Drug: Saline Solution intravenously
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients undergoing thoracotomy surgery Exclusion Criteria: chronic pain, bleeding disorders, renal or hepatic insufficiency, non cooperative patient, Patients with allergies to one of the drugs used in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group ESPB<br>Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine and Saline iv. bolus and infusion (same volume as Group Lidocaine) | Drug: Bupivacaine Hcl 0.25% Inj<br>* Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine<br>Drug: Saline Solution intravenously<br>* Same volume saline solution bolus and infusion as Group Lidocaine<br>|
| Active Comparator: Group Lidocaine<br>1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion and, Ultrasound-guided erector spinae plane block with 20 ml saline | Drug: Saline Solution for Block<br>* Ultrasound-guided erector spinae plane block with 20 ml saline<br>Drug: Lidocaine<br>* 1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion<br>|
| Sham Comparator: Group Control<br>Ultrasound-guided erector spinae plane block with 20 ml saline and, Saline iv. bolus and infusion (same volume as Group Lidocaine) | Drug: Saline Solution for Block<br>* Ultrasound-guided erector spinae plane block with 20 ml saline<br>Drug: Saline Solution intravenously<br>* Same volume saline solution bolus and infusion as Group Lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | First 24 hours total fentanyl consumption with patient controlled analgesia | First 24 hours total opioid consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively. | Postoperative 24 hour |