Liver Transplant DisorderESPLIVPAEDNCT04838314
Perioperative Analgesia by ESP Catheter on Paediatric Recipient for Liver Transplantation
A study testing regional analgesia in people with Liver Transplant Disorder, run by Vinmec Healthcare System at 1 site in Vietnam.
Trial summary
Pediatric Liver transplantation surgery is associated with moderate to severe postoperative pain that is related to large abdominal incision cutting muscles and fascia and the anterior abdominal wall and drains. Read more about this study
- Who is it for?
- Ages 12 months to 15 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
- 12 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2021to 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 12 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Recipient liver transplantation who accepted to participate ( parents or guardians)
Who cannot join
- Refusal participation.
- Allergy to LA
- Intubated ventilated pre-operation
- Severe coagulation disorder
- Coma
- Prediction of large volume liver implanted
Show all 9Show fewer
- After surgery performed Large volume implanted with a need of post operative controlled ventilation
- After surgery performed Organ failure
- After surgery performed Unstable patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Bilateral Continuous Peri Operative Erector Spinae Plane (ESP) Block Improve Analgesia and Reduce Opioid Consumption for Liver Transplantation in Recipient Paediatric Patient
Pediatric Liver transplantation surgery is associated with moderate to severe postoperative pain that is related to large abdominal incision cutting muscles and fascia and the anterior abdominal wall and drains. Peri-operative pain management after this surgery is centered on intravenous opioids, which cannot provide complete pain relief and are responsible for side effects such as vomiting or respiratory depression. Fifty-two per cent of pediatric patients reported moderate to severe pain on the day of surgery and 33% on day 1. 42% of patients reported vomiting. Increasing interest has focused on opioid sparing analgesic strategies to avoid some of the detrimental side effects of opioids. Recently, the focus has been on postoperative regional analgesia after major pediatric in major thoracic or abdominal surgeries. Thoracic epidural anesthesia or paravertebral blocks are efficacious but raise some concerns related to their potential complications especially in Liver transplantation with the risk of coagulation disorders.
Erector spinae plane block (ESPB) is an interfascial plane block whereby Local anesthestic (LA) is injected beneath the iliocostalis, longissimus, and spinalis muscles to achieve multi metameric analgesia for pediatric thoracic, cardiac, or abdominal surgery.
I Investigators' hypothesis is with efficient peri operative regional analgesia will reduce the opioids consumption, allow a very early extubation after such long surgeries and improve the quality of recovery by reducing the side effects of opioids as sedation. nausea vomiting delay of first intake.
Read the detailed description
- Goals: Compare quality of analgesia and quality of recovery between bilateral ESP bilateral catheters versus Opioid analgesia in paediatric patients for liver transplantation reduce the peri operative opioid consumption
- Methodology:
- Selection criteria:
- Age > 1 to 15 years old
- Have a clinical indication for Liver transplantation ( list for surgeries listed in full proposal)
- Agree to participate in the trial ( Parents or guardians)
- Exclusion criteria:
- Refusal participation.
- Allergy to LA
- Intubated ventilated pre-operation
- Severe coagulation disorder
- Coma
- Prediction of large volume liver implanted
- After surgery performed
- Large volume implanted with a need of post operative controlled ventilation
- Organ failure
- Unstable patient
- 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 Transplantation for paediatric recipients: Intra-operative analgesia by Opioid sufentanil and post operative analgesia by patient controled analgesia assisted by nurse opioid morphine based on the protocol established by Prof Lee Vinmec transplantation surgical committee Group 2 (treatment group): Standard peri-operative analgesia for paediatric recipients in institution since we use regional anaesthesia as first line treatment for peri-operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anesthestic (Ropivacaine) based on the guidelines by paediatric society of anesthesiologists and based on our recent article published in regional anaesthesia and pain medicine Sample size: We expected to reduce the peri operative opioid consumption by 85% for liver receipt 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:
The Primary outcome correlation between
- Pain quality evaluated by
- Opioids consumption The secondary outcomes
- Time to extubate
- Time to discharge from Intensive care Unit (ICU) we will create criteria to determinate when patient will discharge from ICU to go to high dependency In most of advanced hospital they don't keep a long time patient in ICU and send the patient to high dependency unit in surgery As in Institution we don't have we will keep the patient in ICU
- Time to discharge from hospital
- Time to first intake
- Any complication related to one type of analgesia
- 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
Peri operative regional analgesia by bilateral ESP catheter for 72h
| Study group | Role | What they receive |
|---|---|---|
| Standard of cares | No intervention | Peri operative analgesia by opioids |
| regional analgesia | Experimental | Peri operative analgesia 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.
peri operative Opioids consumption
Dose of opioids used
Measured: up to day 7 after the end of surgery
Secondary outcomes (5)
Time to extubate
Time to reach the criteria to extubate after the end of the surgery
Measured: up to 6 hours after the end of the surgery
Duration of stay in Intensive care Unit (ICU)
Time to reach the criteria of ICU discharge after liver transplantation
Measured: up to 72 hours after the end of the surgery
Length of stay in hospital
Time to reach the criteria of hospital discharge after liver transplantation
Measured: up to 30 day after the end of the surgery
first intake
Time to have first intake after the end of the surgery
Measured: up to 72hours after the end of the surgery
first mobilisation
Time to have first stand up after the end of the surgery
Measured: up to 72hours after the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Jun 2021
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Why it stopped: No More recruitment 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vinmec Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- philippe Macaire, MD, Principal investigator, VinMEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838314
- Sponsor's protocol ID
- VINMEC-LT-REC-PAED
- Acronym
- ESPLIVPAED
- Status last verified
- Aug 2023
- First submitted
- 1 Apr 2021
- 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 Analgesia and Reduce Opioid Consumption for Liver Transplantation in Recipient Paediatric Patient
- ClinicalTrials.gov ID
- NCT04838314
- Acronym / sponsor ID
- ESPLIVPAED / VINMEC-LT-REC-PAED
- Conditions
- Liver Transplant Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No More recruitment surgeon left the team
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vinmec Healthcare SystemUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 9 Apr 2021 (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.
Pediatric Liver transplantation surgery is associated with moderate to severe postoperative pain that is related to large abdominal incision cutting muscles and fascia and the anterior abdominal wall and drains. Peri-operative pain management after this surgery is centered on intravenous opioids, which cannot provide complete pain relief and are responsible for side effects such as vomiting or respiratory depression. Fifty-two per cent of pediatric patients reported moderate to severe pain on the day of surgery and 33% on day 1. 42% of patients reported vomiting. Increasing interest has focused on opioid sparing analgesic strategies to avoid some of the detrimental side effects of opioids. Recently, the focus has been on postoperative regional analgesia after major pediatric in major thoracic or abdominal surgeries. Thoracic epidural anesthesia or paravertebral blocks are efficacious but raise some concerns related to their potential complications especially in Liver transplantation with the risk of coagulation disorders.
Erector spinae plane block (ESPB) is an interfascial plane block whereby Local anesthestic (LA) is injected beneath the iliocostalis, longissimus, and spinalis muscles to achieve multi metameric analgesia for pediatric thoracic, cardiac, or abdominal surgery.
I Investigators' hypothesis is with efficient peri operative regional analgesia will reduce the opioids consumption, allow a very early extubation after such long surgeries and improve the quality of recovery by reducing the side effects of opioids as sedation. nausea vomiting delay of first intake.
Detailed description
- Goals: Compare quality of analgesia and quality of recovery between bilateral ESP bilateral catheters versus Opioid analgesia in paediatric patients for liver transplantation reduce the peri operative opioid consumption
- Methodology:
- Selection criteria:
- Age > 1 to 15 years old
- Have a clinical indication for Liver transplantation ( list for surgeries listed in full proposal)
- Agree to participate in the trial ( Parents or guardians)
- Exclusion criteria:
- Refusal participation.
- Allergy to LA
- Intubated ventilated pre-operation
- Severe coagulation disorder
- Coma
- Prediction of large volume liver implanted
- After surgery performed
- Large volume implanted with a need of post operative controlled ventilation
- Organ failure
- Unstable patient
- 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 Transplantation for paediatric recipients: Intra-operative analgesia by Opioid sufentanil and post operative analgesia by patient controled analgesia assisted by nurse opioid morphine based on the protocol established by Prof Lee Vinmec transplantation surgical committee Group 2 (treatment group): Standard peri-operative analgesia for paediatric recipients in institution since we use regional anaesthesia as first line treatment for peri-operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anesthestic (Ropivacaine) based on the guidelines by paediatric society of anesthesiologists and based on our recent article published in regional anaesthesia and pain medicine Sample size: We expected to reduce the peri operative opioid consumption by 85% for liver receipt 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:
The Primary outcome correlation between
- Pain quality evaluated by
- Opioids consumption The secondary outcomes
- Time to extubate
- Time to discharge from Intensive care Unit (ICU) we will create criteria to determinate when patient will discharge from ICU to go to high dependency In most of advanced hospital they don't keep a long time patient in ICU and send the patient to high dependency unit in surgery As in Institution we don't have we will keep the patient in ICU
- Time to discharge from hospital
- Time to first intake
- Any complication related to one type of analgesia
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 cares | No intervention | –Peri operative analgesia by opioids |
| regional analgesia | Experimental | Procedure: regional analgesiaPeri operative analgesia by continuous bilateral ESP catheters |
Who may qualify
- Ages
- 12 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Recipient liver transplantation who accepted to participate ( parents or guardians)
Key exclusion criteria (9 listed)
- Refusal participation.
- Allergy to LA
- Intubated ventilated pre-operation
- Severe coagulation disorder
- Coma
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 analgesiaPeri operative regional analgesia by bilateral ESP catheter for 72h | Procedure or surgery | regional analgesia |
Primary outcome
peri operative Opioids consumption
Time frame: up to day 7 after the end of surgery
Dose of opioids used
5 secondary outcomes
Time to extubate
Time frame: up to 6 hours after the end of the surgery
Duration of stay in Intensive care Unit (ICU)
Time frame: up to 72 hours after the end of the surgery
Length of stay in hospital
Time frame: up to 30 day after the end of the surgery
first intake
Time frame: up to 72hours after the end of the surgery
first mobilisation
Time frame: up to 72hours after the end of the surgery
Results and safety
The study was stopped early (reason given: No More recruitment 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
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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. This study is not recruiting at the moment.
philippe Macaire, MD principal investigator
VinMEC
1 site 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 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 1 inclusion and 9 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 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?
The study was stopped early (reason given: No More recruitment 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?
peri operative Opioids consumption (time frame: up to day 7 after the end of surgery). 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.