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Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation (ESPLIVERDON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04570969
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Philippe Macaire, Vinmec Healthcare System

Study Description
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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
Liver Transplant Disorder Procedure: Erector spinae plane block Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled prospective trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of Quality of Life After Live Liver Donation by ESP Peri Operative Analgesia
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. quality of pain relief at rest [ Time Frame: from day 0 = day of surgery to day 180 ]
    Visual analgesic score at rest

  2. quality of pain relief at mouvement [ Time Frame: from day 0 = day of surgery to day 180 ]
    Visual analgesic score at mouvement


Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: from day 0 to 30 days after the day of surgery ]
    Total dose of opioids required

  2. Duration of hospitalisation [ Time Frame: From day = 0 day of the surgery to day to discharge day 15 maximum ]
    Duration of hospitalisation

  3. Quality of recovery [ Time Frame: 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

  4. Patient satisfaction [ Time Frame: 1 month after the surgery ]
    index from 0 not satisfy to 10 extremely satisfied

  5. Quality of life (QOL) after donation [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570969


Locations
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Vietnam
VinMec INternational hospital Recruiting
Hanoi, Vietnam, 100000
Contact: Philippe Macaire, MD    0966103845    ph.macaire@gmail.com   
Sponsors and Collaborators
Vinmec Healthcare System
More Information
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Responsible Party: Philippe Macaire, Director of anesthesia and pain management - Anesthesiologist MD, Vinmec Healthcare System
ClinicalTrials.gov Identifier: NCT04570969    
Other Study ID Numbers: VINMEC LT DON
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No