Opioid UseNCT05706285
Comparing Intrathecal Morphine With Erector Spina Plane Block in Open Gastrectomy Surgery
An observational study of Opioid Use and Post Operative Pain, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Opioid Use, Post Operative Pain, Pain Assessment Scales
- What is being tested?
- Regional Block Comparison
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years old undergoing open gastrectomy surgery in Marmara University Training and Research Hospital
Who may be able to join
- Patients over 18 years old
- Patients undergoing open gastrectomy surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine
Istanbul
About this study
Official title: Comparing Postoperative Analgesic Effects of 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.
- Conditions
- Opioid Use, Post Operative Pain, Pain Assessment Scales
- Being tested
- Regional Block Comparison
- Keywords
- erector spina plane block, intrathecal morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional Block ComparisonProcedure or surgery
Comparing postoperative pain and opioid consumption in groups
| Study group | Role | What they receive |
|---|---|---|
| Erector Spina Plane Block and Intravenous Patient Controlled Analgesia | Not described Receives: Procedure: Regional Block Comparison | |
| Intrathecal Morphine and Intravenous Patient Controlled Analgesia | Not described Receives: Procedure: Regional Block Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 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.
Measured: 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.
Measured: 48 hours
Secondary outcomes (2)
Comparison of the frequency of treatment related complications
Bradycardia, hypotension, sedation, respiratory depression, urinary retention, itching, need for rescue analgesics.
Measured: 48 hours
Participant satisfaction
Whether the patient is very pleased/ satisfied/ unsatisfied/ complainant with the pain treatment will be recorded.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start15 Feb 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beliz Bilgili, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706285
- Sponsor's protocol ID
- MarmaraUniv
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Postoperative Analgesic Effects of Intrathecal Morphine With Erector Spina Plane Block in Open Gastrectomy Surgery
- ClinicalTrials.gov ID
- NCT05706285
- Acronym / sponsor ID
- MarmaraUniv
- Conditions
- Opioid Use, Post Operative Pain, Pain Assessment Scales
- Keywords
- erector spina plane block, intrathecal morphine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spina Plane Block and Intravenous Patient Controlled Analgesia | – | Procedure: Regional Block Comparison |
| Intrathecal Morphine and Intravenous Patient Controlled Analgesia | – | Procedure: Regional Block Comparison |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old undergoing open gastrectomy surgery in Marmara University Training and Research Hospital
Key inclusion criteria (2 listed)
- Patients over 18 years old
- Patients undergoing open gastrectomy surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional Block ComparisonComparing postoperative pain and opioid consumption in groups | Procedure or surgery | Erector Spina Plane Block and Intravenous Patient Controlled Analgesia, Intrathecal Morphine and Intravenous Patient Controlled Analgesia |
Primary outcome
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'
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.
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.
2 secondary outcomes
Comparison of the frequency of treatment related complications
Time frame: 48 hours
Participant satisfaction
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use and Post Operative Pain, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessment with Numeric Rating Scale (NRS) (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.