Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation

NCT ID: NCT04570969

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2024-02-25

Brief 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

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

Conditions

Liver Transplant Disorder

Study Design

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

Study Groups

standard of care

Peri-operative analgesia by opioids

Group Type: NO_INTERVENTION

No interventions assigned to this group

Peri operative regional analgesia

Peri-operative analgesia by Continuous bilateral Erector Spinae Catheters

Group Type: EXPERIMENTAL

Erector spinae plane block

Intervention Type: PROCEDURE

Insertion of bilateral catheters in the intersfacia space of erector spinae muscle

Interventions

Erector spinae plane block

Insertion of bilateral catheters in the intersfacia space of erector spinae muscle

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vinmec Healthcare System

OTHER

Sponsor Role: lead

Responsible Party

Philippe Macaire

Director of anesthesia and pain management - Anesthesiologist MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VinMec INternational hospital

Hanoi, , Vietnam

Site Status: RECRUITING

Countries

Vietnam

Facility Contacts

Philippe Macaire, MD

Role: primary

ph.macaire@gmail.com

0966103845

Other Identifiers

VINMEC LT DON

Identifier Type: -

Identifier Source: org_study_id