Clinical trial NCT04570969: Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation
Official title: Improvement of Quality of Life After Live Liver Donation by ESP Peri Operative Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplant Disorder
Lead sponsor: Vinmec Healthcare System
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled prospective trial
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: quality of pain relief at rest
timeFrame: from day 0 = day of surgery to day 180
measure: quality of pain relief at mouvement
timeFrame: from day 0 = day of surgery to day 180
Secondary outcomes:
measure: Opioid consumption
timeFrame: from day 0 to 30 days after the day of surgery
measure: Duration of hospitalisation
timeFrame: From day = 0 day of the surgery to day to discharge day 15 maximum
measure: Quality of recovery
timeFrame: 1 month after surgery
measure: Patient satisfaction
timeFrame: 1 month after the surgery
measure: Quality of life (QOL) after donation
timeFrame: 1 months and 3 months after surgery
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: VinMec INternational hospital
Study officials:
References: