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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.
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:
Exclusion criteria:
Refusal participation.
Allergy to LA
Intubated ventilated pre-operation
Severe coagulation disorder
Coma
Prediction of large volume liver implanted
After surgery performed
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of cares | No Intervention | Peri operative analgesia by opioids | |
| regional analgesia | Experimental | Peri operative analgesia by continuous bilateral ESP catheters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regional analgesia | Procedure | Peri operative regional analgesia by bilateral ESP catheter for 72h |
|
| Measure | Description | Time Frame |
|---|---|---|
| peri operative Opioids consumption | Dose of opioids used | up to day 7 after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubate | Time to reach the criteria to extubate after the end of the surgery | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| philippe Macaire, MD | VinMEC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VinMec International hospital | Hanoi | Vietnam |
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randomized controlled prospective trial
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| 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 | up to 30 day after the end of the surgery |
| first intake | Time to have first intake after the end of the surgery | up to 72hours after the end of the surgery |
| first mobilisation | Time to have first stand up after the end of the surgery | up to 72hours after the end of the surgery |