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CompletedNCT05706285Updated Mar 28, 2024

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

An observational study in Opioid Use, Post Operative Pain and Pain Assessment Scales, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Marmara University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
63
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Opioid Use
  • Post Operative Pain
  • Pain Assessment Scales

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Keywords

  • erector spina plane block
  • intrathecal morphine
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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's enrollment of 63 is below the median of 102 across 607 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureRegional Block Comparison

    Comparing postoperative pain and opioid consumption in groups

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What researchers measure

Primary outcomes

  1. 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'

    Time frame: 48 hours

  2. 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.

    Time frame: 48 hours

  3. 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.

    Time frame: 48 hours

Secondary outcomes

  1. Comparison of the frequency of treatment related complications

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

    Time frame: 48 hours

  2. Participant satisfaction

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

    Time frame: 48 hours

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Study locations

1 site
  • Marmara University School of Medicine
    Istanbul, Turkey
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05706285
Lead sponsor
Marmara University
Responsible party
Beliz Bilgili (Associate Professor, Marmara University Pendik Training and Research Hospital) — Principal investigator
First posted
Jan 31, 2023
Start date
Feb 15, 2023
Primary completion
Feb 1, 2024
Completion
Feb 1, 2024
Last update
Mar 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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