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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
Goals:
Compare quality of pain relief and quality of life between bilateral ESP bilateral catheters Vs Opioid analgesia in donor patients for liver donation.
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)
Project outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard of care | No Intervention | Peri-operative analgesia by opioids | |
| Peri operative regional analgesia | Experimental | Peri-operative analgesia by Continuous bilateral Erector Spinae Catheters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spinae plane block | Procedure | Insertion of bilateral catheters in the intersfacia space of erector spinae muscle |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VinMec INternational hospital | Recruiting | Hanoi | 100000 | Vietnam |
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Randomized controlled prospective trial
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| 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 |