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

NCT05706285 | Completed

• 1 other identifier: MarmaraUniv
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Post Operative Pain; Pain Assessment Scales

Keywords

erector spina plane block; intrathecal morphine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Comparison of the frequency of treatment related complications

  48 hours

• Participant satisfaction

  48 hours

Study Arms (2)

Erector Spina Plane Block and Intravenous Patient Controlled Analgesia

Procedure: Regional Block Comparison

Intrathecal Morphine and Intravenous Patient Controlled Analgesia

Procedure: Regional Block Comparison

Interventions

Regional Block Comparison PROCEDURE

Comparing postoperative pain and opioid consumption in groups

Erector Spina Plane Block and Intravenous Patient Controlled Analgesia; Intrathecal Morphine and Intravenous Patient Controlled Analgesia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients over 18 years old
• Patients undergoing open gastrectomy surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 31, 2023
• Study Start: February 15, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

TU (1)