Perioperative Analgesia by ESP Catheter on Recipient for Liver Transplantation (ESPLIVERRec)

Does Bilateral Continuous Peri Operative Erector Spinae Plane (ESP) Block Improve the Enhanced Recovery Program After Liver Transplantation in Recipient Patient

Enhanced recovery after surgery (ERAS) programs were developed by Prof Henrik Kehlet in Denmark to reduce the hospitalization and improve the surgical outcomes. In these programs pain relief by regional analgesia techniques are highly recommended to reduced as much as possible the opioids used with their side effects. This program was created for colo-rectal surgeries and extended to other surgeries. In Liver transplants different programs has been described top reduce the use of peri-operative opioids but no with the ESP Animal and molecular studies in chronic pain showed the activation of glial cells, Monocytes and lymphocite K similar to the reaction during severe septis with immune reaction and toll like receptor activation. Regional anaesthesia analgesia is blocking this activation of Tool Like Receptors (TLR4) One of the discharge criteria after liver transplantation is the equilibrium of plasmatic cyclosporin Our hypothesis is with regional analgesia to avoid any immune disorder due to pain and reach earlier the discharge criteria than with standard analgesia Improve the quality of recovery and reduce the hospitalization stay after liver transplantation

Study Overview

• Status: Terminated
• Conditions: Liver Transplant Disorder
• Intervention / Treatment: Procedure: regional analgesia

Detailed Description

1. Goals:

   Compare quality of analgesia and quality of recovery between bilateral ESP bilateral catheters versus Opioid analgesia in adult included in an enhanced recovery program after liver transplantation Show that the addition of peri-operative regional analgesia improves the enhanced recovery program after open liver transplant in recipient patient .

2. Methodology:

   •Selection criteria: Age > 18 years old Have a clinical indication for Liver transplantation ( list for surgeries listed in full proposal) Agree to participate in the trial

   •Exclusion criteria: Use of chronic opioid Contra-indication tom perform ESP catheter (Infection near puncture point, Severe thoracic scoliosis, allergy to local anaesthetics) A diagnosis of a chronic pain condition Depression 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 : Intra operative analgesia by Opioid Sufentanil and post operative analgesia by Patient Controlled analgesia (PCA) opioid morphine Group 2 (treatment group): Standard peri-operative analgesia for Liver donation in our hospital since we use regional anaesthesia as first line treatment for peri operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anaesthetic (Ropivacaine)

   Sample size: We expected to reduce the length of stay for liver receipt from 11 ± 2.22 days in ERAS group to 8 ± 2.22 days in the 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 40 patients (20 patients each group)

3. Project outcomes:

   • Primary outcomes Length of stay in Hospital Our estimation based on our previous studies for ESP and the literature for ERAS programs in open heart surgeries
   • Secondary outcomes Time to extubation Duration of stay in ICU Time to 1st mobilisation Opioid consumption in relation with VAS Rest and mobilization

Patient satisfaction:

• Quality of recovery scoring 15 items (QOR 15)
• Pain at 1 month rest and mobilization + Quality of Life scoring (QOL36)

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Vinmec international hospital
  • Hanoi, Vietnam
    • VinMec INternational hopspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age clinical indication for liver transplantation agree to participate and signed consent

Exclusion Criteria:

• Use of chronic opioid contra indication to perform ESP cathters Diagnosis of a chronic pain condition except liver disease Psychiatric or depression disorder allergy to local anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard of care; Peri operative analgesia by opioid
Experimental: Continuous regiona analgesia; Peri operative algesia by continuous bilateral ESP catheters	Procedure: regional analgesia; Insertion of bilateral ESP catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in hospital	Time to reach the criteria of hospital discharge after liver transplantation	up to 30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of stay in Intensive care Unit (ICU)	Time to reach the criteria of ICU discharge after liver transplantation	up to 72 hours
Quality of recovery: score	Score on 15 criteria for quality of recovery from 0= very poor to 150 = excellent	up to 30 days

Collaborators and Investigators

• Sponsor: Vinmec Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: VINMEC LT REC

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