Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation — ESPLIVERDON  

Liver Transplant Disorder Clinical Trial

Official title: Improvement of Quality of Life After Live Liver Donation by ESP Peri Operative Analgesia

Status Recruiting

Clinical Trial Summary

Liver donors have a significant risk to develop persistent and chronic pain around 20 to 30% affecting social and professional life (17%) up to 1 year after the surgery.

To donate a part of liver is a beautiful gift reason why the pain relief must be improved.

Meta-analysis showed that the best prevention against post operative chronic pain are the techniques blocking the pain signal (regional anaesthesia) Patients after liver donation are still in pain even in 2020 with the best multimodal analgesia medications.

Erector sinae Plane Block (ESP) ESP will block the signal and improve the pain relief we hope to demonstrate that it will reduce the risk to develop post operative chronic pain and improve the quality of recovery and the quality of life after liver donation

Clinical Trial Description

1. Goals:

Compare quality of pain relief and quality of life between bilateral ESP bilateral catheters Vs Opioid analgesia in donor patients for liver donation.

2. Methodology:

• Selection criteria: Age > 18 years old Be volunteer to donate liver Agree to participate in the trial

• Exclusion criteria: Use of chronic opioids Contra-indication tom perform ESP catheter (Infection near puncture point, Severe thoracic scoliosis, allergie to local anesthestics) A diagnosis of a chronic pain conditionDepression or other psychiatric diagnosis

• 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 donation : Intraoperative analgesia by Opioid sufentanil and post operative analgesia by PCA opioid morphine Group 2 (treatement group): Standard peri-operative analgesia for liver donation in since Investigators use regional anaesthesia as first line treatement for peri operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anesthestic (Ropivacaine)

Sample size: investigators expected to increase the Quality of LIfe (QoL) score (using under-the-curve area) from 36·9 for the ERAS group to 38.3 for ESP group 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 24 patients (12 patients each group)

3. Project outcomes:

• Primary outcomes Quality of pain relief with opioid consumption

• Secondary outcomes Duration of hospitalisation participants satisfaction Quality of recovery (QOR 16) Pain at 1 & 3 months rest and mobilization + QOL ;

Related Conditions & MeSH terms

• Liver Transplant Disorder

• NCT number: NCT04570969
• Study type: Interventional
• Source: Vinmec Healthcare System
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Completion date: February 25, 2024