Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation

  • STATUS
    Recruiting
  • days left to enroll
    7
  • participants needed
    24
  • sponsor
    Vinmec Healthcare System
Updated on 27 January 2021

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

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 369 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

Details
Condition Liver Transplant Disorder
Treatment erector spinae plane block
Clinical Study IdentifierNCT04570969
SponsorVinmec Healthcare System
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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