Laparoscopic Bariatric Surgery and Erector Spinae Plane Block

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effect of erector spinae plane (ESP) block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery

Detailed Description
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Laparoscopic sleeve gastrectomy is one of the most common surgical procedure that is chosen for bariatric surgery. Postoperative pain after bariatric surgery can de significant. Narcotic analgesics are often used to manage the postoperative pain in patients undergoing bariatric surgery. However, these drugs causes many undesirable adverse effects such as nausea, constipation, and respiratory depression. The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia after bariatric surgery. The aim of the study is to evaluate the effect of ESP block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery

Official Title
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Comparison of the Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery

Conditions
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Obesity, Postoperative Pain, Bariatric Surgery

Intervention / Treatment
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* Procedure: ESP block group
* Procedure: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective bariatric surgery American Society of Anesthesiology (ASA) II-III 18 - 65 years body mass index (BMI) 40-60 kg/m2 Exclusion Criteria: ASA ≥4 under 18 years of age or over 65 years of age declining to give written informed consent have neurological and/or psychiatric disorders cooperation cannot be established accompanying laparoscopic cholecystectomy or paraumbilical hernia repair history of bariatric surgery the block cannot be applied due to bleeding disorders or localized skin infection at the injection site with hepatic, neuromuscular, cardiac and/or renal failure history of allergy to the local anesthetics patients undergoing open surgery

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESP block group<br>Before anaesthesia induction; bilateral ESP block will be performed under the guidance of USG. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. Standardized postoperative tramadol i.v. patient controlled analgesia (PCA) protocol will be performed (3 mg/ml, total volume 100 ml, 10 mg bolus dose, 20 min locked period, without continuous delivery, no basal infusion). | Procedure: ESP block group<br>* USG probe will be placed in a longitudinal parasagittal orientation 3 cm lateral to T7 spinous process. The erector spinae muscles will be identified hyperechoic transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 21-gauge 10-cm needle was inserted using an in-plane superior-to-inferior approach or an out-plane approach. Following confirmation of the correct position of the needle with 5 ml normal saline, a dose of 20 ml %0.25 bupivacaine will be administered. The same procedure will be performed at the other site (totally 40 ml %0.25 bupivacaine). Standard pain follow up and monitorization will be performed.<br>|
| Sham Comparator: Control group<br>Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. Standardized postoperative tramadol i.v. PCA analgesia protocol will be performed (3 mg/ml, total volume 100 ml, 10 mg bolus dose, 20 min locked period, without continuous delivery, no basal infusion). | Procedure: Control group<br>* The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesia consumption | postoperative 24 hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Numeric Rating Scale (NRS) score | postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible). | postoperative 0, 1, 3, 6, 12, 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector spinae plane (ESP) block, Laparoscopic bariatric surgery, Obesity, Postoperative pain