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OpenTrials
Completed

NCT Number: NCT05706285

Comparing 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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regional Block Comparison

Procedure

Comparing postoperative pain and opioid consumption in groups

Primary outcomes

  1. Postoperative pain assessment with Numeric Rating Scale (NRS)

    Time frame: 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'

  2. Postoperative pain assessment with Clinically Aligned Pain Assessment (CAPA) Tool

    Time frame: 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.

  3. Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device

    Time frame: 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 outcomes

  1. Comparison of the frequency of treatment related complications

    Time frame: 48 hours

    Bradycardia, hypotension, sedation, respiratory depression, urinary retention, itching, need for rescue analgesics.

  2. Participant satisfaction

    Time frame: 48 hours

    Whether the patient is very pleased/ satisfied/ unsatisfied/ complainant with the pain treatment will be recorded.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2023
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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