Liver TransplantNCT06857331
Perioperative Analgesia With Erector Spinae Plane Block in Liver Transplant Recipients
A study testing Erector Spinae Plane Block using 0.2% ropivacaine in people with Liver Transplant and Erector Spina Plan Block, run by Bogomolets National Medical University at 1 site in Ukraine.
Trial summary
The goal of this clinical trial is to learn if ESP block is safe and effective for perioperative analgesia in patients undergoing liver transplant. The main question it aims to answer are Is ESP block safe and has a minimum side effects, like hematoma? Is it effective for perioperative analgesia? Researchers will… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplant, Erector Spina Plan Block
- What is being tested?
- Erector Spinae Plane Block using 0.2% ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUkraine
- Study dates
- 5 May 2024to 10 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- impaired liver function - cirrhosis or chronic liver disease with the development of hypocoagulation (APTT > 35 sec, INR > 1.5), thrombocytopenia, patients requiring major abdominal surgery, age > 18 years, written consent to participate in the study was obtained
Who cannot join
- Platelet count <50x109, failed ESP catheterization unilateral or bilateral, failed epidural anesthesia attempt, history of allergy or hypersensitivity to local anesthetics, hepatopulmonary syndrome, patients on mechanical ventilation before surgery, patients on CRRT before surgery, refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site, 1 recruiting
- Recruiting
Universal Hospital Oberig
Kyiv
Nazarii Mysynchuk, +380731624586, n.mysynchuk@oberig.ua
Nazarii Mysynchuk
About this study
Official title: Optimization of Perioperative Analgesia With Erector Spinae Plane Block During Major Abdominal Surgeries in Patients With Impaired Liver Function
The goal of this clinical trial is to learn if ESP block is safe and effective for perioperative analgesia in patients undergoing liver transplant. The main question it aims to answer are Is ESP block safe and has a minimum side effects, like hematoma? Is it effective for perioperative analgesia? Researchers will compare the results to a group of patients who underwent liver transplants without any regional anaesthesia techniques.
Participants will receive bilateral thoracic ESP block on the day of the transplantation with a subsequent bilateral catheterization.
- Conditions
- Liver Transplant, Erector Spina Plan Block
- Being tested
- Erector Spinae Plane Block using 0.2% ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block using 0.2% ropivacaineProcedure or surgery
Bilateral thoracic ESP block on the day of the transplantation with a subsequent catheterization will be suggested for the patients. In case of their written consent for the participation in the study this procedure will be performed on the day of the operation. 0.2% ropivacaine is going to be used throughout all the perioperative period.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant recipients without regional anesthesia | No intervention | Liver transplant recipients without regional anesthesia |
| Liver transplant recipients with regional anesthesia (ESP) | Experimental | ESP bilateral thoracic with a subsequent catheterization. Receives: Procedure: Erector Spinae Plane Block using 0.2% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction postoperative
Pain assessment with scores
Measured: from enrollment to the 2nd postoperative day
Opioid reduction intraoperatively
The amount of intraoperative fentanyl
Measured: from enrollment to the end of the operation
Need for opioids postoperatively
Need for opioids postoperatively
Measured: from enrollment to the 2nd postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start5 May 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazarii Mysynchuk, Bogomolets National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857331
- Sponsor's protocol ID
- 190
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Perioperative Analgesia With Erector Spinae Plane Block During Major Abdominal Surgeries in Patients With Impaired Liver Function
- ClinicalTrials.gov ID
- NCT06857331
- Acronym / sponsor ID
- 190
- Conditions
- Liver Transplant, Erector Spina Plan Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 4 Mar 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.
The goal of this clinical trial is to learn if ESP block is safe and effective for perioperative analgesia in patients undergoing liver transplant. The main question it aims to answer are Is ESP block safe and has a minimum side effects, like hematoma? Is it effective for perioperative analgesia? Researchers will compare the results to a group of patients who underwent liver transplants without any regional anaesthesia techniques.
Participants will receive bilateral thoracic ESP block on the day of the transplantation with a subsequent bilateral catheterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver transplant recipients without regional anesthesia | No intervention | –Liver transplant recipients without regional anesthesia |
| Liver transplant recipients with regional anesthesia (ESP) | Experimental | Procedure: Erector Spinae Plane Block using 0.2% ropivacaineESP bilateral thoracic with a subsequent catheterization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- impaired liver function - cirrhosis or chronic liver disease with the development of hypocoagulation (APTT > 35 sec, INR > 1.5), thrombocytopenia, patients requiring major abdominal surgery, age > 18 years, written consent to participate in the study was obtained
Key exclusion criteria (1 listed)
- Platelet count <50x109, failed ESP catheterization unilateral or bilateral, failed epidural anesthesia attempt, history of allergy or hypersensitivity to local anesthetics, hepatopulmonary syndrome, patients on mechanical ventilation before surgery, patients on CRRT before surgery, refusal to participate in the study
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 |
|---|---|---|
| Erector Spinae Plane Block using 0.2% ropivacaineBilateral thoracic ESP block on the day of the transplantation with a subsequent catheterization will be suggested for the patients. In case of their written consent for the participation in the study this procedure will be performed on the day of the operation. 0.2% ropivacaine is going to be used throughout all the perioperative period. | Procedure or surgery | Liver transplant recipients with regional anesthesia (ESP) |
Primary outcome
Pain reduction postoperative
Time frame: from enrollment to the 2nd postoperative day
Pain assessment with scores
Opioid reduction intraoperatively
Time frame: from enrollment to the end of the operation
The amount of intraoperative fentanyl
Need for opioids postoperatively
Time frame: from enrollment to the 2nd postoperative day
Need for opioids postoperatively
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 4 Mar 2025.
- Individual participant dataSharing planned: No
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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 Erector Spinae Plane Block using 0.2% ropivacaine in people with Liver Transplant and Erector Spina Plan Block, run by Bogomolets National Medical University at 1 site in Ukraine.
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 1 inclusion and 1 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 4 Mar 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 Ukraine. 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 Nazarii Mysynchuk (+380731624586, n.mysynchuk@oberig.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction postoperative (time frame: from enrollment to the 2nd postoperative day). 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 4 Mar 2025.