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

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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Transplant Disorder
• Intervention / Treatment: Procedure: Erector spinae plane block

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Recruiting
    • Vinmec international hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age more than 18 and less than 61
• Be volunteer to donate liver
• agree to participate to study and consent signed
• Risk of americain society of anesthesiologists score ASA from 1 to 5 score ASA must be 1 only

Exclusion Criteria:

• Use of chronic opioid before the surgery
• A diagnosis of chronic pain condition
• Contra indication to perform ESP catheter
• allergy to local anesthestics
• Depression or psychiatric diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: standard of care; Peri-operative analgesia by opioids
EXPERIMENTAL: Peri operative regional analgesia; Peri-operative analgesia by Continuous bilateral Erector Spinae Catheters	Procedure: Erector spinae plane block; Insertion of bilateral catheters in the intersfacia space of erector spinae muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of pain relief at rest	Visual analgesic score at rest	from day 0 = day of surgery to day 180
quality of pain relief at mouvement	Visual analgesic score at mouvement	from day 0 = day of surgery to day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Total dose of opioids required	from day 0 to 30 days after the day of surgery
Duration of hospitalisation	Duration of hospitalisation	From day = 0 day of the surgery to day to discharge day 15 maximum
Quality of recovery	Score based on Table quality of recovery including 15 criteria from 0 to 10 each ) = poor 10 = excellent poor recovery scale 0 to 150	1 month after surgery
Patient satisfaction	index from 0 not satisfy to 10 extremely satisfied	1 month after the surgery
Quality of life (QOL) after donation	The Form QOL (36) is a 36-item, patient-reported survey of patient health and mesure the surgical outcomes. The SF-36 is a measure of health status	1 months and 3 months after surgery

Collaborators and Investigators

• Sponsor: Vinmec Healthcare System

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ANTICIPATED): November 30, 2023
• Study Completion (ANTICIPATED): February 25, 2024

Study Registration Dates

• First Submitted: September 20, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (ACTUAL): September 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VINMEC LT DON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No