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

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use; Post Operative Pain; Pain Assessment Scales
• Intervention / Treatment: Procedure: Regional Block Comparison

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Marmara University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old undergoing open gastrectomy surgery in Marmara University Training and Research Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Erector Spina Plane Block and Intravenous Patient Controlled Analgesia	Procedure: Regional Block Comparison; Comparing postoperative pain and opioid consumption in groups
Intrathecal Morphine and Intravenous Patient Controlled Analgesia	Procedure: Regional Block Comparison; Comparing postoperative pain and opioid consumption in groups

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: erector spina plane block; intrathecal morphine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: MarmaraUniv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No