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

Sponsor
Marmara University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05706285
Collaborator
(none)
60
10.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Regional Block Comparison

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparing Postoperative Analgesic Effects of Intrathecal Morphine With Erector Spina Plane Block in Open Gastrectomy Surgery
Anticipated Study Start Date :
Jan 20, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

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

  1. Comparison of the frequency of treatment related complications [48 hours]

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

  2. Participant satisfaction [48 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beliz Bilgili, Associate Professor, Marmara University Pendik Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05706285
Other Study ID Numbers:
  • MarmaraUniv
First Posted:
Jan 31, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beliz Bilgili, Associate Professor, Marmara University Pendik Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2023