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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Insertion of bilateral catheters in the intersfacia space of erector spinae muscle
VinMec INternational hospital
Hanoi, Vietnam
RECRUITINGquality of pain relief at rest
Visual analgesic score at rest
Time frame: from day 0 = day of surgery to day 180
quality of pain relief at mouvement
Visual analgesic score at mouvement
Time frame: from day 0 = day of surgery to day 180
Opioid consumption
Total dose of opioids required
Time frame: from day 0 to 30 days after the day of surgery
Duration of hospitalisation
Duration of hospitalisation
Time frame: 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
Time frame: 1 month after surgery
Patient satisfaction
index from 0 not satisfy to 10 extremely satisfied
Time frame: 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
Time frame: 1 months and 3 months after surgery
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