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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706285
• Other study ID #: MarmaraUniv
• Status: Completed
• Start date: February 15, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Regional Block Comparison
Comparing postoperative pain and opioid consumption in groups

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

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