Liver Transplant DisorderESPLIVERRecNCT04584151
Perioperative Analgesia by ESP Catheter on Recipient for Liver Transplantation
A study testing regional analgesia in people with Liver Transplant Disorder, run by Vinmec Healthcare System at 2 sites in Vietnam.
Trial summary
Enhanced recovery after surgery (ERAS) programs were developed by Prof Henrik Kehlet in Denmark to reduce the hospitalization and improve the surgical outcomes. In these programs pain relief by regional analgesia techniques are highly recommended to reduced as much as possible the opioids used with their side effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant Disorder
- What is being tested?
- regional analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Nov 2020to 14 Aug 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age clinical indication for liver transplantation agree to participate and signed consent
Who cannot join
- Use of chronic opioid contra indication to perform ESP cathters Diagnosis of a chronic pain condition except liver disease Psychiatric or depression disorder allergy to local anesthetics
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
VinMec INternational hospital
Hanoi, 100000
VinMec INternational hopspital
Hanoi
About this study
Official title: Does Bilateral Continuous Peri Operative Erector Spinae Plane (ESP) Block Improve the Enhanced Recovery Program After Liver Transplantation in Recipient Patient
Enhanced recovery after surgery (ERAS) programs were developed by Prof Henrik Kehlet in Denmark to reduce the hospitalization and improve the surgical outcomes. In these programs pain relief by regional analgesia techniques are highly recommended to reduced as much as possible the opioids used with their side effects. This program was created for colo-rectal surgeries and extended to other surgeries. In Liver transplants different programs has been described top reduce the use of peri-operative opioids but no with the ESP Animal and molecular studies in chronic pain showed the activation of glial cells, Monocytes and lymphocite K similar to the reaction during severe septis with immune reaction and toll like receptor activation. Regional anaesthesia analgesia is blocking this activation of Tool Like Receptors (TLR4) One of the discharge criteria after liver transplantation is the equilibrium of plasmatic cyclosporin Our hypothesis is with regional analgesia to avoid any immune disorder due to pain and reach earlier the discharge criteria than with standard analgesia Improve the quality of recovery and reduce the hospitalization stay after liver transplantation
Read the detailed description
- Goals: Compare quality of analgesia and quality of recovery between bilateral ESP bilateral catheters versus Opioid analgesia in adult included in an enhanced recovery program after liver transplantation Show that the addition of peri-operative regional analgesia improves the enhanced recovery program after open liver transplant in recipient patient .
- Methodology: •Selection criteria: Age > 18 years old Have a clinical indication for Liver transplantation ( list for surgeries listed in full proposal) Agree to participate in the trial •Exclusion criteria: Use of chronic opioid Contra-indication tom perform ESP catheter (Infection near puncture point, Severe thoracic scoliosis, allergy to local anaesthetics) A diagnosis of a chronic pain condition Depression or other psychiatric diagnosis
- Study design: Prospective Randomized Controlled Trial. Patients who agree to join the study will be randomized into 2 groups: Group 1 (Control group): standard of care in Liver donation : Intra operative analgesia by Opioid Sufentanil and post operative analgesia by Patient Controlled analgesia (PCA) opioid morphine Group 2 (treatment group): Standard peri-operative analgesia for Liver donation in our hospital since we use regional anaesthesia as first line treatment for peri operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anaesthetic (Ropivacaine) Sample size: We expected to reduce the length of stay for liver receipt from 11 ± 2.22 days in ERAS group to 8 ± 2.22 days in the ESP group The sample size of 10 patients per group is required to detect such changes assuming a confidence interval of 95% with a power of 90% and alpha = 0.05. Considering 20% of drop-out, the total sample size is 40 patients (20 patients each group)
- Project outcomes:
- Primary outcomes Length of stay in Hospital Our estimation based on our previous studies for ESP and the literature for ERAS programs in open heart surgeries
- Secondary outcomes Time to extubation Duration of stay in ICU Time to 1st mobilisation Opioid consumption in relation with VAS Rest and mobilization
Patient satisfaction:
- Quality of recovery scoring 15 items (QOR 15)
- Pain at 1 month rest and mobilization + Quality of Life scoring (QOL36)
- Conditions
- Liver Transplant Disorder
- Being tested
- regional analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional analgesiaProcedure or surgery
Insertion of bilateral ESP catheters
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | Peri operative analgesia by opioid |
| Continuous regiona analgesia | Experimental | Peri operative algesia by continuous bilateral ESP catheters Receives: Procedure: regional analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in hospital
Time to reach the criteria of hospital discharge after liver transplantation
Measured: up to 30 day
Secondary outcomes (2)
Duration of stay in Intensive care Unit (ICU)
Time to reach the criteria of ICU discharge after liver transplantation
Measured: up to 72 hours
Quality of recovery: score
Score on 15 criteria for quality of recovery from 0= very poor to 150 = excellent
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Nov 2020
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Why it stopped: Surgeon left the team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled prospective trial
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vinmec Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584151
- Sponsor's protocol ID
- VINMEC LT REC
- Acronym
- ESPLIVERRec
- Status last verified
- Aug 2023
- First submitted
- 21 Sep 2020
- Last updated
- 21 Aug 2023
- 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Bilateral Continuous Peri Operative Erector Spinae Plane (ESP) Block Improve the Enhanced Recovery Program After Liver Transplantation in Recipient Patient
- ClinicalTrials.gov ID
- NCT04584151
- Acronym / sponsor ID
- ESPLIVERRec / VINMEC LT REC
- Conditions
- Liver Transplant Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Surgeon left the team
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Vinmec Healthcare SystemUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 12 Oct 2020 (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.
Enhanced recovery after surgery (ERAS) programs were developed by Prof Henrik Kehlet in Denmark to reduce the hospitalization and improve the surgical outcomes. In these programs pain relief by regional analgesia techniques are highly recommended to reduced as much as possible the opioids used with their side effects. This program was created for colo-rectal surgeries and extended to other surgeries. In Liver transplants different programs has been described top reduce the use of peri-operative opioids but no with the ESP Animal and molecular studies in chronic pain showed the activation of glial cells, Monocytes and lymphocite K similar to the reaction during severe septis with immune reaction and toll like receptor activation. Regional anaesthesia analgesia is blocking this activation of Tool Like Receptors (TLR4) One of the discharge criteria after liver transplantation is the equilibrium of plasmatic cyclosporin Our hypothesis is with regional analgesia to avoid any immune disorder due to pain and reach earlier the discharge criteria than with standard analgesia Improve the quality of recovery and reduce the hospitalization stay after liver transplantation
Detailed description
- Goals: Compare quality of analgesia and quality of recovery between bilateral ESP bilateral catheters versus Opioid analgesia in adult included in an enhanced recovery program after liver transplantation Show that the addition of peri-operative regional analgesia improves the enhanced recovery program after open liver transplant in recipient patient .
- Methodology: •Selection criteria: Age > 18 years old Have a clinical indication for Liver transplantation ( list for surgeries listed in full proposal) Agree to participate in the trial •Exclusion criteria: Use of chronic opioid Contra-indication tom perform ESP catheter (Infection near puncture point, Severe thoracic scoliosis, allergy to local anaesthetics) A diagnosis of a chronic pain condition Depression or other psychiatric diagnosis
- Study design: Prospective Randomized Controlled Trial. Patients who agree to join the study will be randomized into 2 groups: Group 1 (Control group): standard of care in Liver donation : Intra operative analgesia by Opioid Sufentanil and post operative analgesia by Patient Controlled analgesia (PCA) opioid morphine Group 2 (treatment group): Standard peri-operative analgesia for Liver donation in our hospital since we use regional anaesthesia as first line treatment for peri operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anaesthetic (Ropivacaine) Sample size: We expected to reduce the length of stay for liver receipt from 11 ± 2.22 days in ERAS group to 8 ± 2.22 days in the ESP group The sample size of 10 patients per group is required to detect such changes assuming a confidence interval of 95% with a power of 90% and alpha = 0.05. Considering 20% of drop-out, the total sample size is 40 patients (20 patients each group)
- Project outcomes:
- Primary outcomes Length of stay in Hospital Our estimation based on our previous studies for ESP and the literature for ERAS programs in open heart surgeries
- Secondary outcomes Time to extubation Duration of stay in ICU Time to 1st mobilisation Opioid consumption in relation with VAS Rest and mobilization
Patient satisfaction:
- Quality of recovery scoring 15 items (QOR 15)
- Pain at 1 month rest and mobilization + Quality of Life scoring (QOL36)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled prospective trial
| Arm | Type | Receives |
|---|---|---|
| standard of care | No intervention | –Peri operative analgesia by opioid |
| Continuous regiona analgesia | Experimental | Procedure: regional analgesiaPeri operative algesia by continuous bilateral ESP catheters |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age clinical indication for liver transplantation agree to participate and signed consent
Key exclusion criteria (1 listed)
- Use of chronic opioid contra indication to perform ESP cathters Diagnosis of a chronic pain condition except liver disease Psychiatric or depression disorder allergy to local anesthetics
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 analgesiaInsertion of bilateral ESP catheters | Procedure or surgery | Continuous regiona analgesia |
Primary outcome
Length of stay in hospital
Time frame: up to 30 day
Time to reach the criteria of hospital discharge after liver transplantation
2 secondary outcomes
Duration of stay in Intensive care Unit (ICU)
Time frame: up to 72 hours
Quality of recovery: score
Time frame: up to 30 days
Results and safety
The study was stopped early (reason given: Surgeon left the team). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Liver Transplant Disorder
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regional analgesia in people with Liver Transplant Disorder, run by Vinmec Healthcare System at 2 sites in Vietnam.
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: stopped early, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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 was stopped early (reason given: Surgeon left the team). Results are not available in the source record.
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?
Length of stay in hospital (time frame: up to 30 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 21 Aug 2023.