Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Main purpose of this prospective single center randomized study is to compare the analgesic effect of ultrasound guided Unilateral Oblique Subcostal Transversus Abdominis Plane (TAP),unilateral Erector Spinae Plane (ESP) blocks and Port site infiltration of local anesthetic in subjects undergoing laparoscopic cholecystectomy. Total 100 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent laparoscopic cholecystectomy will recruit to the study.

Official Title
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Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy

Conditions
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Postoperative Pain, Regional Anesthesia

Intervention / Treatment
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* Procedure: Unilateral ESP Block
* Procedure: Unilateral OSTAP Block
* Procedure: Injection of Local Anesthetic to Trocar Insertion
* Drug: intravenous patient controlled analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA Status 1-2 patients Exclusion criteria Patients with a body mass index (BMI) of >40kg/m2 ASA score of >III Previous abdominal surgery Pregnant or breastfeeding patients Patients with coagulopathy Known local anesthetic allergy infection at the injection site

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unilateral ESP Block<br>Before general anaesthesia, Ultrasound guided unilateral ESP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours. | Procedure: Unilateral ESP Block<br>* USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture<br>Drug: intravenous patient controlled analgesia<br>* All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.<br>|
| Active Comparator: Unilateral OSTAP block<br>Under general anaesthesia, Ultrasound guided unilateral OSTAP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours. | Procedure: Unilateral OSTAP Block<br>* USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture<br>Drug: intravenous patient controlled analgesia<br>* All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.<br>|
| Active Comparator: Injection of Local Anesthetic to Trocar Insertion<br>After the laparoscopic surgery was completed, the trocar incision sites were closed. Following the infiltration rules, local anesthetic (15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine) was applied to the trocar sites of skin, fascia, muscle, and preperitoneal area by the surgical team after the operation. A total of 20 mL of local anesthetic was used, with 6 mL for trocar sites of 10 mm, and 4 mL for trocar sites of 5 mm .Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours. | Procedure: Injection of Local Anesthetic to Trocar Insertion<br>* Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.<br>Drug: intravenous patient controlled analgesia<br>* All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.<br>|
| Sham Comparator: multimodal analgesia<br>Perioperative and postoperative routine analgesic protocol will be performed with no additional regional anesthesia method.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours. | Drug: intravenous patient controlled analgesia<br>* All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours. | 24 hours | 
| Postoperative pain scores: NRS | Postoperative pain assessment will apply with numerical rating scale. These scores will record till the postoperative 24 th hours. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative nause and vomiting | The patient with nausea and vomiting will be recorded. | 24 hours |