Perioperative Analgesia by ESP Catheter on Paediatric Recipient for Liver Transplantation

NCT04838314 | Terminated DMC

• 1 other identifier: VINMEC-LT-REC-PAED
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant Disorder

Outcome Measures

Primary Outcomes (1)

• peri operative Opioids consumption

  Dose of opioids used

  up to day 7 after the end of surgery

Secondary Outcomes (5)

• Time to extubate

  up to 6 hours after the end of the surgery

• Duration of stay in Intensive care Unit (ICU)

  up to 72 hours after the end of the surgery

• Length of stay in hospital

  up to 30 day after the end of the surgery

• first intake

  up to 72hours after the end of the surgery

• first mobilisation

  up to 72hours after the end of the surgery

Study Arms (2)

Standard of cares

NO INTERVENTION

Peri operative analgesia by opioids

regional analgesia

EXPERIMENTAL

Peri operative analgesia by continuous bilateral ESP catheters

Procedure: regional analgesia

Interventions

regional analgesia PROCEDURE

Peri operative regional analgesia by bilateral ESP catheter for 72h

regional analgesia

Eligibility Criteria

• Age: 12 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Recipient liver transplantation who accepted to participate ( parents or guardians)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vinmec Healthcare System: lead

Study Sites (1)

VinMec International hospital

Hanoi, Vietnam

Location

Study Officials

• philippe Macaire, MD

  VinMEC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled prospective trial

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 9, 2021
• Study Start: June 1, 2021
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)