The Effect of Ultrasound-guided Erector Spinae Block on Postoperative in Patients Undergoing Nephrectomy.

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the postoperative effect of erector spinae block in patients undergoing nephrectomy that causes both visceral and somatic pain.

Detailed Description
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After being informed and potential risks about the study, all patients have given written consent will undergo 24 hours screening for the analgesic effect of erector spinae block after nephrectomy. Patients meeting the criteria were randomly selected in double-blind manner 1:1 ratio to erector spiane block or not.

Official Title
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The Effect of Ultrasound-guided Erector Spinae Block on Postoperative Analgesic Consumption in Patients Undergoing Nephrectomy. Prospective Randomized Single-center Study.

Conditions
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Nephrectomy

Intervention / Treatment
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* Procedure: erector spinae block (ESP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To undergo partial or total nephrectomy surgery To be in ASA I-II classification To be between the ages of 18-65. Not having problems that prevent erector spinae block application such as local anesthetic drug allergy, infection at the injection site, and structural anomaly. Being in good mental and psychological health To accept to participate in the study. Exclusion Criteria: Being in ASA III or IV class with a high risk of anesthesia Being outside the age range of 18-65 Having problems such as local anesthetic drug allergy, infection at the injection site, and structural anomaly prevents block application. Not being mentally and psychologically healthy Those who are allergic to the active substance, patients using antiepileptic drugs Those with severe hepatic and renal failure Those who have long-term use of nonsteroidal anti-inflammatory and opioid analgesic, Those with diabetes and other neuropathic diseases Patients who cannot use patient-controlled analgesia (PCA) device

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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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: Single Group Assignment
Interventional Model Description: It is a single centre, randomized, prospective method comparison study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erector spinae group<br>All blocks will be done under general anesthesia. Using a 6-10 MHz linear ultrasound (Esaote my-lab 6, Italy). With the ultrasonography device of our clinic, the side of the nephrectomy surgery will be performed with the position of the nephrectomy, and the position (lateral decubitus) is given to the patient. The thoracic 10th vertebra will be found under ultrasound guidance. After the T12 transverse protrusion is seen by sliding 3 cm laterally from the midline, 30 ml of 0.25% Bupivacaine will be injected under the erector spinae muscle above it. | Procedure: erector spinae block (ESP)<br>* Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra<br>|
| Placebo Comparator: placebo group<br>No block transaction will be applied to this group. Only postoperative analgesia methods will be used for this group as specified in the protocol. | Procedure: erector spinae block (ESP)<br>* Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) | Numerical Rating Scale (NRS) will be used for postoperative evaluation. NRS is a segmented digital version of the visual analog scale. Selecting an integer (0-10 integers) by a responder in (VAS). It is accepted as one dimensional-the measure of pain intensity in adults. The 11-point numerical scale ranges from 0 to 10, representing a pain (no pain). 10 (as bad pain as you can imagine), or (the worst pain imaginable). | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery analgesia | Secondary outcome measures will be routine (paracetamol or tramadol PCA) or recovery. Analgesic use will be recorded within the first 24 hours. | 24 hours | 
| postoperative nausea and vomiting | The severity of nausea and vomiting 4-point scale (none, mild, moderate, and severe). As will be recorded by the nurses in the ward. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spinae block, nephrectomy, ultrasound