Comparing Intrathecal Morphine With Erector Spina Plane Block in Open Gastrectomy Surgery

Study Overview
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Brief Summary
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Open gastrectomy causes severe postoperative pain due to wide surgical incisions, retraction of the abdominal wall and direct manipulation of the visceral organs. It leads to delayed postoperative recovery, increased medical expenses and poor surgical outcomes. Epidural analgesia, intrathecal morphine and patient-controlled analgesia are frequently used in the postoperative pain management of abdominal surgeries. Intrathecal morphine is applied as a standard protocol in many centers due to its ease of application and effective pain control. However; it has undesirable effects such as postoperative nausea-vomiting, itching and most importantly respiratory depression. Regional interfascial plane blocks, such as erector spina plane block, have recently been popular in clinical practice to provide postoperative pain control. Erector spina plane block, when placed preoperatively, is expected to reduce opioid consumption and improve outcomes. The primary implication of this study is to compare postoperative pain scores and opioid consumption. It is also aimed to compare the effectiveness of Numeric Rating Scale and Clinically Aligned Pain Assessment Tool used in postoperative pain assesment.

Official Title
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Comparing Postoperative Analgesic Effects of Intrathecal Morphine With Erector Spina Plane Block in Open Gastrectomy Surgery

Conditions
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Opioid Use, Post Operative Pain, Pain Assessment Scales

Intervention / Treatment
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* Procedure: Regional Block Comparison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old Patients undergoing open gastrectomy surgery Exclusion Criteria: Patients with solid organ dysfunction Patients who receive opioid or corticosteroid medication prior to surgery Patients with bleeding diathesis Patients with psychiatric disorders Patients who can not be contacted after surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Erector Spina Plane Block and Intravenous Patient Controlled Analgesia<br> | Procedure: Regional Block Comparison<br>* Comparing postoperative pain and opioid consumption in groups<br>|
| Intrathecal Morphine and Intravenous Patient Controlled Analgesia<br> | Procedure: Regional Block Comparison<br>* Comparing postoperative pain and opioid consumption in groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain assessment with Numeric Rating Scale (NRS) | In a Numerical Rating Scale (NRS), patients are asked to choose the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas ten represents 'the worst pain ever possible' | 48 hours | 
| Postoperative pain assessment with Clinically Aligned Pain Assessment (CAPA) Tool | CAPA tool functions as a conversation guide to gather categorical information during the course of a natural conversation. It focuses on how comfortable the patient is, whether discomfort is improving or worsening, whether the patient is able to participate in recovery activities and if pain is interfering with sleep.The clinician then codes and documents the conversation. Patient does not rate any scale or check boxes of responses. | 48 hours | 
| Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device | Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous morphine consumption will be recorded via PCA device, then it will be documented in mg/kg units. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the frequency of treatment related complications | Bradycardia, hypotension, sedation, respiratory depression, urinary retention, itching, need for rescue analgesics. | 48 hours | 
| Participant satisfaction | Whether the patient is very pleased/ satisfied/ unsatisfied/ complainant with the pain treatment will be recorded. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spina plane block, intrathecal morphine