Clinical trial NCT04838314: Perioperative Analgesia by ESP Catheter on Paediatric Recipient for Liver Transplantation
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Transplant Disorder
Lead sponsor: Vinmec Healthcare System
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled prospective trial
Primary purpose: TREATMENT

Brief 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. 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: 1. 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
2. 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)
3. 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

Eligibility criteria: Inclusion Criteria:

* Recipient liver transplantation who accepted to participate ( 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
* After surgery performed Organ failure
* After surgery performed Unstable patient

Primary outcomes:
measure: peri operative Opioids consumption
timeFrame: up to day 7 after the end of surgery
Secondary outcomes:
measure: Time to extubate
timeFrame: up to 6 hours after the end of the surgery
measure: Duration of stay in Intensive care Unit (ICU)
timeFrame: up to 72 hours after the end of the surgery
measure: Length of stay in hospital
timeFrame: up to 30 day after the end of the surgery
measure: first intake
timeFrame: up to 72hours after the end of the surgery
measure: first mobilisation
timeFrame: up to 72hours after the end of the surgery
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: VinMec International hospital
Study officials:
affiliation: VinMEC
name: philippe Macaire, MD
role: PRINCIPAL_INVESTIGATOR
References: