Opioid UseNCT06346860
Comparing Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery
A study testing Regional Block Comparison in people with Opioid Use and Postoperative Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Opioid Use, Postoperative Pain
- What is being tested?
- Regional Block Comparison
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 29 Jul 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients over 18 years old
- Patients undergoing major abdominal 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 Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery
Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach.
- Conditions
- Opioid Use, Postoperative Pain
- Being tested
- Regional Block Comparison
- Keywords
- intrathecal morphine, Modified Thoracoabdominal Nerve Block Through Perichondral Approach
- 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 |
|---|---|---|
| Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and PCA | Active comparator | Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and Intravenous Patient Controlled Analgesia Receives: Procedure: Regional Block Comparison |
| Intrathecal Morphine and Intravenous Patient Controlled Analgesia | Placebo comparator | Intrathecal Morphine 200 mcg and Intravenous Patient Controlled Analgesia (1 mg/ml morphine, 1 cc bolus, 7 min. locked Receives: Procedure: Regional Block Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (3)
Postoperative pain assessment with Numeric Rating Scale (NRS)
In a Numerical Rating Scale (NRS), patients are asked to choose the number
Measured: 48 hours
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 posted4 Apr 2024
- Study start15 Apr 2024
- Primary completion29 Jul 2024
- Study completion29 Jul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beliz Bilgili, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346860
- Sponsor's protocol ID
- 09.2024.241
- Status last verified
- Feb 2026
- First submitted
- 29 Mar 2024
- Last updated
- 5 Feb 2026
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Postoperative Analgesic Effects of Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06346860
- Acronym / sponsor ID
- 09.2024.241
- Conditions
- Opioid Use, Postoperative Pain
- Keywords
- intrathecal morphine, Modified Thoracoabdominal Nerve Block Through Perichondral Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 4 Apr 2024 (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.
Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and PCA | Active comparator | Procedure: Regional Block ComparisonModified Thoracoabdominal Nerve BlockThrough Perichondral Approach and Intravenous Patient Controlled Analgesia |
| Intrathecal Morphine and Intravenous Patient Controlled Analgesia | Placebo comparator | Procedure: Regional Block ComparisonIntrathecal Morphine 200 mcg and Intravenous Patient Controlled Analgesia (1 mg/ml morphine, 1 cc bolus, 7 min. locked |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years old
- Patients undergoing major abdominal 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 | Intrathecal Morphine and Intravenous Patient Controlled Analgesia, Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and PCA |
Primary outcome
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.
3 secondary outcomes
Postoperative pain assessment with Numeric Rating Scale (NRS)
Time frame: 48 hours
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 5 Feb 2026.
- 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?
A study testing Regional Block Comparison in people with Opioid Use and Postoperative 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 5 Feb 2026. 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. Some participants in this study may receive a placebo. 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?
Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device (time frame: 48 hours). 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 5 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.