Liver Transplant DisorderESPLIVERDONNCT04570969
Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation
A study testing Erector spinae plane block in people with Liver Transplant Disorder, run by Vinmec Healthcare System at 1 site in Vietnam.
Trial summary
Liver donors have a significant risk to develop persistent and chronic pain around 20 to 30% affecting social and professional life (17%) up to 1 year after the surgery. To donate a part of liver is a beautiful gift reason why the pain relief must be improved. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Transplant Disorder
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Nov 2020to 25 Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age more than 18 and less than 61
- Be volunteer to donate liver
- agree to participate to study and consent signed
- Risk of americain society of anesthesiologists score ASA from 1 to 5 score ASA must be 1 only
Who cannot join
- Use of chronic opioid before the surgery
- A diagnosis of chronic pain condition
- Contra indication to perform ESP catheter
- allergy to local anesthestics
- Depression or psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
VinMec INternational hospital
Hanoi, 100000
Philippe Macaire, MD, 0966103845, ph.macaire@gmail.com
About this study
Official title: Improvement of Quality of Life After Live Liver Donation by ESP Peri Operative Analgesia
Liver donors have a significant risk to develop persistent and chronic pain around 20 to 30% affecting social and professional life (17%) up to 1 year after the surgery.
To donate a part of liver is a beautiful gift reason why the pain relief must be improved.
Read more
Meta-analysis showed that the best prevention against post operative chronic pain are the techniques blocking the pain signal (regional anaesthesia) Patients after liver donation are still in pain even in 2020 with the best multimodal analgesia medications.
Erector sinae Plane Block (ESP) ESP will block the signal and improve the pain relief we hope to demonstrate that it will reduce the risk to develop post operative chronic pain and improve the quality of recovery and the quality of life after liver donation
Read the detailed description
- Goals: Compare quality of pain relief and quality of life between bilateral ESP bilateral catheters Vs Opioid analgesia in donor patients for liver donation.
- Methodology:
- Selection criteria: Age > 18 years old Be volunteer to donate liver Agree to participate in the trial
- Exclusion criteria: Use of chronic opioids Contra-indication tom perform ESP catheter (Infection near puncture point, Severe thoracic scoliosis, allergie to local anesthestics) A diagnosis of a chronic pain conditionDepression 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 : Intraoperative analgesia by Opioid sufentanil and post operative analgesia by PCA opioid morphine Group 2 (treatement group): Standard peri-operative analgesia for liver donation in since Investigators use regional anaesthesia as first line treatement for peri operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anesthestic (Ropivacaine) Sample size: investigators expected to increase the Quality of LIfe (QoL) score (using under-the-curve area) from 36·9 for the ERAS group to 38.3 for 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 24 patients (12 patients each group)
- Project outcomes:
- Primary outcomes Quality of pain relief with opioid consumption
- Secondary outcomes Duration of hospitalisation participants satisfaction Quality of recovery (QOR 16) Pain at 1 \& 3 months rest and mobilization + QOL
- Conditions
- Liver Transplant Disorder
- Being tested
- Erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Insertion of bilateral catheters in the intersfacia space of erector spinae muscle
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | Peri-operative analgesia by opioids |
| Peri operative regional analgesia | Experimental | Peri-operative analgesia by Continuous bilateral Erector Spinae Catheters Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of pain relief at rest
Visual analgesic score at rest
Measured: from day 0 = day of surgery to day 180
quality of pain relief at mouvement
Visual analgesic score at mouvement
Measured: from day 0 = day of surgery to day 180
Secondary outcomes (5)
Opioid consumption
Total dose of opioids required
Measured: from day 0 to 30 days after the day of surgery
Duration of hospitalisation
Duration of hospitalisation
Measured: From day = 0 day of the surgery to day to discharge day 15 maximum
Quality of recovery
Score based on Table quality of recovery including 15 criteria from 0 to 10 each ) = poor 10 = excellent poor recovery scale 0 to 150
Measured: 1 month after surgery
Patient satisfaction
index from 0 not satisfy to 10 extremely satisfied
Measured: 1 month after the surgery
Quality of life (QOL) after donation
The Form QOL (36) is a 36-item, patient-reported survey of patient health and mesure the surgical outcomes. The SF-36 is a measure of health status
Measured: 1 months and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Nov 2020
- Primary completion30 Nov 2023 (estimated)
- Study completion25 Feb 2024 (estimated)
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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vinmec Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Macaire, Vinmec Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570969
- Sponsor's protocol ID
- VINMEC LT DON
- Acronym
- ESPLIVERDON
- Status last verified
- Nov 2022
- First submitted
- 20 Sep 2020
- Last updated
- 15 Nov 2022
- 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 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Quality of Life After Live Liver Donation by ESP Peri Operative Analgesia
- ClinicalTrials.gov ID
- NCT04570969
- Acronym / sponsor ID
- ESPLIVERDON / VINMEC LT DON
- Conditions
- Liver Transplant Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Vinmec Healthcare SystemUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 25 Feb 2024 (estimated)
- First posted
- 30 Sep 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.
Liver donors have a significant risk to develop persistent and chronic pain around 20 to 30% affecting social and professional life (17%) up to 1 year after the surgery.
To donate a part of liver is a beautiful gift reason why the pain relief must be improved.
Meta-analysis showed that the best prevention against post operative chronic pain are the techniques blocking the pain signal (regional anaesthesia) Patients after liver donation are still in pain even in 2020 with the best multimodal analgesia medications.
Erector sinae Plane Block (ESP) ESP will block the signal and improve the pain relief we hope to demonstrate that it will reduce the risk to develop post operative chronic pain and improve the quality of recovery and the quality of life after liver donation
Detailed description
- Goals: Compare quality of pain relief and quality of life between bilateral ESP bilateral catheters Vs Opioid analgesia in donor patients for liver donation.
- Methodology:
- Selection criteria: Age > 18 years old Be volunteer to donate liver Agree to participate in the trial
- Exclusion criteria: Use of chronic opioids Contra-indication tom perform ESP catheter (Infection near puncture point, Severe thoracic scoliosis, allergie to local anesthestics) A diagnosis of a chronic pain conditionDepression 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 : Intraoperative analgesia by Opioid sufentanil and post operative analgesia by PCA opioid morphine Group 2 (treatement group): Standard peri-operative analgesia for liver donation in since Investigators use regional anaesthesia as first line treatement for peri operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anesthestic (Ropivacaine) Sample size: investigators expected to increase the Quality of LIfe (QoL) score (using under-the-curve area) from 36·9 for the ERAS group to 38.3 for 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 24 patients (12 patients each group)
- Project outcomes:
- Primary outcomes Quality of pain relief with opioid consumption
- Secondary outcomes Duration of hospitalisation participants satisfaction Quality of recovery (QOR 16) Pain at 1 \& 3 months rest and mobilization + QOL
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 opioids |
| Peri operative regional analgesia | Experimental | Procedure: Erector spinae plane blockPeri-operative analgesia by Continuous bilateral Erector Spinae Catheters |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age more than 18 and less than 61
- Be volunteer to donate liver
- agree to participate to study and consent signed
- Risk of americain society of anesthesiologists score ASA from 1 to 5 score ASA must be 1 only
Key exclusion criteria (5 listed)
- Use of chronic opioid before the surgery
- A diagnosis of chronic pain condition
- Contra indication to perform ESP catheter
- allergy to local anesthestics
- Depression or psychiatric diagnosis
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 blockInsertion of bilateral catheters in the intersfacia space of erector spinae muscle | Procedure or surgery | Peri operative regional analgesia |
Primary outcome
quality of pain relief at rest
Time frame: from day 0 = day of surgery to day 180
Visual analgesic score at rest
quality of pain relief at mouvement
Time frame: from day 0 = day of surgery to day 180
Visual analgesic score at mouvement
5 secondary outcomes
Opioid consumption
Time frame: from day 0 to 30 days after the day of surgery
Duration of hospitalisation
Time frame: From day = 0 day of the surgery to day to discharge day 15 maximum
Quality of recovery
Time frame: 1 month after surgery
Patient satisfaction
Time frame: 1 month after the surgery
Quality of life (QOL) after donation
Time frame: 1 months and 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- 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.
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 in people with Liver Transplant Disorder, run by Vinmec Healthcare System at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 15 Nov 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of pain relief at rest (time frame: from day 0 = day of surgery to day 180). The study lists 2 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 15 Nov 2022.