ESPLIVERDON: Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
- 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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Primary outcomes Quality of pain relief with opioid consumption
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Secondary outcomes Duration of hospitalisation participants satisfaction Quality of recovery (QOR 16) Pain at 1 & 3 months rest and mobilization + QOL
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: standard of care Peri-operative analgesia by opioids |
|
| Experimental: Peri operative regional analgesia Peri-operative analgesia by Continuous bilateral Erector Spinae Catheters |
Procedure: Erector spinae plane block
Insertion of bilateral catheters in the intersfacia space of erector spinae muscle
|
Outcome Measures
Primary Outcome Measures
- quality of pain relief at rest [from day 0 = day of surgery to day 180]
Visual analgesic score at rest
- quality of pain relief at mouvement [from day 0 = day of surgery to day 180]
Visual analgesic score at mouvement
Secondary Outcome Measures
- Opioid consumption [from day 0 to 30 days after the day of surgery]
Total dose of opioids required
- Duration of hospitalisation [From day = 0 day of the surgery to day to discharge day 15 maximum]
Duration of hospitalisation
- Quality of recovery [1 month after surgery]
Score based on Table quality of recovery including 15 criteria from 0 to 10 each ) = poor 10 = excellent poor recovery scale 0 to 150
- Patient satisfaction [1 month after the surgery]
index from 0 not satisfy to 10 extremely satisfied
- Quality of life (QOL) after donation [1 months and 3 months after surgery]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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age more than 18 and less than 61
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Be volunteer to donate liver
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agree to participate to study and consent signed
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Risk of americain society of anesthesiologists score ASA from 1 to 5 score ASA must be 1 only
Exclusion Criteria:
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Use of chronic opioid before the surgery
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A diagnosis of chronic pain condition
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Contra indication to perform ESP catheter
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allergy to local anesthestics
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Depression or psychiatric diagnosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VinMec INternational hospital | Hanoi | Vietnam | 100000 |
Sponsors and Collaborators
- Vinmec Healthcare System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VINMEC LT DON