Comparing Intrathecal Morphine With Erector Spina Plane Block in Open Gastrectomy Surgery
- Conditions
- Opioid UsePain Assessment ScalesPost Operative Pain
- Interventions
- Procedure: Regional Block Comparison
- Registration Number
- NCT05706285
- Lead Sponsor
- Marmara University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Patients over 18 years old
- Patients undergoing open gastrectomy surgery
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intrathecal Morphine and Intravenous Patient Controlled Analgesia Regional Block Comparison - Erector Spina Plane Block and Intravenous Patient Controlled Analgesia Regional Block Comparison -
- Primary Outcome Measures
Name Time Method Postoperative pain assessment with Clinically Aligned Pain Assessment (CAPA) Tool 48 hours 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.
Postoperative pain assessment with Numeric Rating Scale (NRS) 48 hours 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'
Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device 48 hours 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.
- Secondary Outcome Measures
Name Time Method Comparison of the frequency of treatment related complications 48 hours Bradycardia, hypotension, sedation, respiratory depression, urinary retention, itching, need for rescue analgesics.
Participant satisfaction 48 hours Whether the patient is very pleased/ satisfied/ unsatisfied/ complainant with the pain treatment will be recorded.
Trial Locations
- Locations (1)
Marmara University School of Medicine
🇹🇷Istanbul, Turkey