Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation

Liver Transplant Disorder Clinical Trial

— ESPLIVERDON  

Official title:

Improvement of Quality of Life After Live Liver Donation by ESP Peri Operative Analgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04570969
• Other study ID #: VINMEC LT DON
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: February 25, 2024

Study information

• Verified date: November 2022
• Source: Vinmec Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: February 25, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant Disorder

Intervention

Procedure:
• Erector spinae plane block
Insertion of bilateral catheters in the intersfacia space of erector spinae muscle

Locations

Country	Name	City	State
Vietnam	VinMec INternational hospital	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vinmec Healthcare System

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of pain relief at rest	Visual analgesic score at rest	from day 0 = day of surgery to day 180
Primary	quality of pain relief at mouvement	Visual analgesic score at mouvement	from day 0 = day of surgery to day 180
Secondary	Opioid consumption	Total dose of opioids required	from day 0 to 30 days after the day of surgery
Secondary	Duration of hospitalisation	Duration of hospitalisation	From day = 0 day of the surgery to day to discharge day 15 maximum
Secondary	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
Secondary	Patient satisfaction	index from 0 not satisfy to 10 extremely satisfied	1 month after the surgery
Secondary	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