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
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