Perioperative Analgesia by ESP Catheter on Paediatric Recipient for Liver Transplantation

NCT ID: NCT04838314

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-08-14

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

Conditions

Liver Transplant Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of cares

Peri operative analgesia by opioids

Group Type: NO_INTERVENTION

No interventions assigned to this group

regional analgesia

Peri operative analgesia by continuous bilateral ESP catheters

Group Type: EXPERIMENTAL

regional analgesia

Intervention Type: PROCEDURE

Peri operative regional analgesia by bilateral ESP catheter for 72h

Interventions

regional analgesia

Peri operative regional analgesia by bilateral ESP catheter for 72h

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vinmec Healthcare System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

philippe Macaire, MD

Role: PRINCIPAL_INVESTIGATOR

VinMEC

Locations

VinMec International hospital

Hanoi, , Vietnam

Countries

Vietnam

Other Identifiers

VINMEC-LT-REC-PAED

Identifier Type: -

Identifier Source: org_study_id