Ketamine and Magnesium in Erector Spinae Plane Block

Study Overview
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Brief Summary
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In this study, it will aimed to evaluate the effect of magnesium sulfate and ketamine HCl added to local anesthetic on postoperative pain management in the ultrasound-guided erector spina plane (ESP) block in patients will undergo video-assisted thoracoscopic surgery.

Detailed Description
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Patients who will undergo lung resection with elective video-assisted thoracoscopic surgery will be included in the study. After routine monitoring, general anesthesia induction, and intubation with a double-lumen tube, patients who are placed in a lateral position will receive an ESP block at the T5 level, accompanied by ultrasonography, for postoperative analgesia. For this purpose; Group I (control group) 0.5% bupivacaine 20 ml, Group II 0.5% bupivacaine 20 ml+150 mg MgSO4, Group III 0% ,5 bupivacaine 20 ml+2 mg/kg ketamine HCl will be administered. In all groups, the total volume will completed to 25 ml with 0.9% NaCl. After surgery, hemodynamic values (heart rate, systolic and diastolic blood pressure), oxygen saturation, VAS scores (at rest and effort), Ramsey sedation score, patients satisfaction scores, PCA morphine consumption, additional analgesic requirements, and side effects will be recorded.

Official Title
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Comparison of Analgesic Effects of Magnesium Sulphate and Ketamine Added to 0.5% Bupivacaine for Erector Spinae Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery

Conditions
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Postoperative Analgesia

Intervention / Treatment
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* Drug: Bupivacain
* Drug: Magnesium sulfate
* Drug: Ketamine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lung resection with video-assisted thoracoscopy, voluntarily agree to participate in the study, over 18 years old, ASA I-III Exclusion Criteria: ASA>III Coagulation disorders or anticoagulant agent therapy, Allergy or hypersensitivity to any drug to be will be used in the study, Epilepsy, High intracranial pressure, Unwillingness to participate in the study Inability to use the PCA device

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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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>Erector spinae plane block with 20 mL 0.5% bupivacaine | Drug: Bupivacain<br>* Bupivacaine is a local anesthetic agent commonly used in ESP block.<br>|
| Active Comparator: magnesium group<br>Erector spinae plane block with 20 mL 0.5% bupivacaine+150 mg magnesium sulphate | Drug: Bupivacain<br>* Bupivacaine is a local anesthetic agent commonly used in ESP block.<br>Drug: Magnesium sulfate<br>* Magnesium is an adjuvant agent that can be added to the local anesthetic agent to increase analgesic effectiveness..<br>|
| Active Comparator: ketamine group<br>Erector spinae plane block with 20 mL 0.5% bupivacaine+2 mg/kg ketamine | Drug: Bupivacain<br>* Bupivacaine is a local anesthetic agent commonly used in ESP block.<br>Drug: Ketamine Hydrochloride<br>* Ketamine Hydrochloride is an also adjuvant agent that can be added to the local anesthetic to increase analgesic effectiveness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores | postoperative pain scores will recorded used Visual Analog Scale (VAS, 0= no pain, 10=worst pain) | Change from baseline pain scores at 24 hours | 
| morphine consumption | At the end of the surgery, patients will allowed to use the patient controlled analgesia (PCA) device. The PCA will deliver bolus doses of morphine (0,02 mg/kg) every 10 minutes without a background infusion. | Change from baseline morphine consumption at 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects | All of patients will visited in the thoracic surgery ward after surgery and side effects (if occured) will recorded. | postoperative 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spinae plane block, magnesium sulphate, ketamine HCl, bupivacaine, analgesia