Liver TransplantationNCT07123740
Comparison of the Postoperative Analgesic Effects of ITM and Bi-level ESPB in Liver Transplantation Donors
A study testing Intrathecal Morphine and Bi-level Erector Spinae Plane Block in people with Liver Transplantation and Pain Management, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Liver transplantation is a life-saving procedure for patients with end-stage liver disease, and postoperative pain management is critical for optimizing donor recovery and overall outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation, Pain Management
- What is being tested?
- Intrathecal Morphine and Bi-level Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2025to 24 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) score I-II
- Body Mass Index (BMI) between 18-30 kg/m2
Who cannot join
- Patients under 18 and over 65 years of age
- ASA score III and above
- Patients with a history of bleeding diathesis
- BMI below 18 or above 30 kg/m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Altındağ, Ankara, 06000
Atakan Sezgi, M.D., 00905323327000, kansezgi@gmail.com
Jülide Ergil, Professor, 00905323469216, julideergil@hotmail.com
About this study
Official title: Comparison of the Postoperative Analgesic Effects of Intrathecal Morphine and Bi-level Erector Spinae Plane Block in Liver Transplantation Donors
Liver transplantation is a life-saving procedure for patients with end-stage liver disease, and postoperative pain management is critical for optimizing donor recovery and overall outcomes. Poorly controlled pain following donor hepatectomy may reduce quality of life, delay mobilization, and contribute to the development of chronic pain syndromes.
Regional anesthesia techniques, such as intrathecal morphine and erector spinae plane block, have been utilized to enhance postoperative analgesia and reduce perioperative opioid requirements, potentially minimizing opioid-related adverse effects.
In this study, we aimed to compare the postoperative analgesic efficacy of intrathecal morphine and Bi-level erector spinae plane block in living liver donors.
- Conditions
- Liver Transplantation, Pain Management
- Being tested
- Intrathecal Morphine, Bi-level Erector Spinae Plane Block
- Keywords
- Liver Transplantation, Intrathecal Morphine, Erector Spinae Plane Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineProcedure or surgery
An intrathecal injection of morphine 300μg will be administered at the L3-L4 or L4-L5 level.
Additionally, in the postoperative period a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
Bi-level Erector Spinae Plane BlockProcedure or surgery
Bi-level erector spinae plane block will be performed on the patients using a total of 40 ml of 0.25% bupivacaine under ultrasound guidance.
Additionally, in the postoperative period a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine | Active comparator | An intrathecal injection of morphine 300μg will be administered at the L3-L4 or L4-L5 level.
In the intraoperative period, intravenous meperidine 0.5 mg/kg will be given 30min before the end of surgery. Receives: Procedure: Intrathecal Morphine |
| Bi-level Erector Spinae Plane Block | Active comparator | After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T8 spinous process, 10 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process. Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T10 spinous process. Finally, 10 ml of 0.25% bupivacaine hydrochloride will be injected cranio-caudally into the interfacial space below the erector spinae muscle, above the transverse process.
This procedure will be performed bilaterally. A total of 40 ml of 0.25% bupivacaine will be injected for bilateral and bi-level ESPB application.
In the intraoperative period, intravenous meperidine 0.5 mg/kg will be given 30min before the end of surgery. Receives: Procedure: Bi-level Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.
Measured: On the operation day
Secondary outcomes (2)
Intraoperative opioid consumption
Remifentanil consumption for intraoperative period will be recorded
Measured: Intraoperative period
Postoperative Opioid Consumption
Opioid consumption for 24 hours will be recorded
Measured: On the operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start18 Aug 2025
- Primary completion10 Jul 2026 (estimated)
- Study completion24 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Atakan Sezgi, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123740
- Sponsor's protocol ID
- AEŞH-EK-2025-155
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Effects of Intrathecal Morphine and Bi-level Erector Spinae Plane Block in Liver Transplantation Donors
- ClinicalTrials.gov ID
- NCT07123740
- Acronym / sponsor ID
- AEŞH-EK-2025-155
- Conditions
- Liver Transplantation, Pain Management
- Keywords
- Liver Transplantation, Intrathecal Morphine, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 24 Jul 2026 (estimated)
- First posted
- 14 Aug 2025 (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.
Liver transplantation is a life-saving procedure for patients with end-stage liver disease, and postoperative pain management is critical for optimizing donor recovery and overall outcomes. Poorly controlled pain following donor hepatectomy may reduce quality of life, delay mobilization, and contribute to the development of chronic pain syndromes.
Regional anesthesia techniques, such as intrathecal morphine and erector spinae plane block, have been utilized to enhance postoperative analgesia and reduce perioperative opioid requirements, potentially minimizing opioid-related adverse effects.
In this study, we aimed to compare the postoperative analgesic efficacy of intrathecal morphine and Bi-level erector spinae plane block in living liver donors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine | Active comparator | Procedure: Intrathecal MorphineAn intrathecal injection of morphine 300μg will be administered at the L3-L4 or L4-L5 level. In the intraoperative period, intravenous meperidine 0.5 mg/kg will be given 30min before the end of surgery. |
| Bi-level Erector Spinae Plane Block | Active comparator | Procedure: Bi-level Erector Spinae Plane BlockAfter the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T8 spinous process, 10 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process. Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T10 spinous process. Finally, 10 ml of 0.25% bupivacaine hydrochloride will be injected cranio-caudally into the interfacial space below the erector spinae muscle, above the transverse process. This procedure will be performed bilaterally. A total of 40 ml of 0.25% bupivacaine will be injected for bilateral and bi-level ESPB application. In the intraoperative period, intravenous meperidine 0.5 mg/kg will be given 30min before the end of surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) score I-II
- Body Mass Index (BMI) between 18-30 kg/m2
Key exclusion criteria (4 listed)
- Patients under 18 and over 65 years of age
- ASA score III and above
- Patients with a history of bleeding diathesis
- BMI below 18 or above 30 kg/m2
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 |
|---|---|---|
| Intrathecal MorphineAn intrathecal injection of morphine 300μg will be administered at the L3-L4 or L4-L5 level. Additionally, in the postoperative period a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. | Procedure or surgery | Intrathecal Morphine |
| Bi-level Erector Spinae Plane BlockBi-level erector spinae plane block will be performed on the patients using a total of 40 ml of 0.25% bupivacaine under ultrasound guidance. Additionally, in the postoperative period a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. | Procedure or surgery | Bi-level Erector Spinae Plane Block |
Primary outcome
Pain Scores
Time frame: On the operation day
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.
2 secondary outcomes
Intraoperative opioid consumption
Time frame: Intraoperative period
Postoperative Opioid Consumption
Time frame: On the operation day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Morphine and Bi-level Erector Spinae Plane Block in people with Liver Transplantation and Pain Management, run by Ankara Etlik City Hospital 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Atakan Sezgi (00905323327000, kansezgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: On the operation day). 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 19 Aug 2025.