Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?

Study Overview
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Brief Summary
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This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.

Detailed Description
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Although percutaneous nephrolithotomy(PNL) is a minimally invasive procedure, it causes severe postoperative pain due to dilatation of the renal capsule and parenchymal duct and peritubal distension of the nephrostomy tube. PNL-related pain has a limited response to oral and intravenous treatments. The primary aim of our study is to investigate the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL. Our secondary aim is determining if any possible clinical effect of ESPB in terms of serial peak expiratory flow measurements, postoperative agitation score of the patient (Riker Score), ambulation time, length of hospital stay.

Official Title
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SHOULD THE ERECTOR SPİNAE PLANE BLOCK BE APPLIED IN THE PAIN MANAGEMENT OF PERCUTANOUS NEPHROLITOTOMY SURGERY?

Conditions
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Postoperative Pain, Nephrolithotomy, Percutaneous, Erector Spinae Plane Block

Intervention / Treatment
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* Procedure: erector spinae block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing PNL between 18-65 years old Exclusion Criteria: serious cardiac, respiratory, hepatic, renal or haemotologic disease mental disorder and hearing problem anxiety, depression and / or other psychiatric disorders pregnancy refusal of patient Allergy or contraindications to drugs used in the study ASA > 2 Inflammation or infection over injection site Obese patients BMI ≥35/

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1:Conventional intravenous analgesia<br>Conventional intravenous analgesia applied according to surgeon's preference | |
| Active Comparator: Group 2:ESPB<br>A 6-13 MHz linear probe was used for ultrasound-guided ESPB (Logiq e, General Electric, USA,) performed at the T11 level. The transverse process was detected by sliding the transducer 3-4 cm laterally from the midline, and after identification of the transverse process, a 20-gauge 100mm insulated echogenic needle (Vygon locoplex, France) was used | Procedure: erector spinae block<br>* we administer 15 cc of 0.5% bupivacaine between the erector spine muscle and the transverse process. The distribution of bupivacain was observed on ultrasound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart. | postoperative 24 hours | 
| Dynamic Visual Analog Scale | the amount of pain during mobilization, deep breathing or coughing that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart | postoperative 24 hours | 
| Peak Expiratory Flow Rate( PEFR) | maximum speed of expiration as measured with a peak flow meter | postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for first analgesic requirement | Time between end of surgery and patients first analgesic demand | 24 hours | 
| ambulation time | first postoperative mobilization time of the patient | 5 days | 
| length of hospital stay | day of hospitalization | 1 week | 
| Rikert Agitation Scale | postoperative agitation score unarousable very sedated sedated calm and cooperative agitated very agitated dangerous agitation | 24 hours | 
| nausea and vomiting | incidence of nausea and vomiting | 24 hours | 
| patient satisfaction with anesthesia and analgesia | 4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4) | 24 hour | 
| starting oral intake | first oral intake | 48 hours | 
| urinary catheter releated pain score(Visual Analog Scale) | the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart. | postoperative 24 hours | 
| surgeon satisfaction with anesthesia and analgesia | 4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4) | 24 hour |