Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation

NCT04570969 | Unknown DMC

• 1 other identifier: VINMEC LT DON
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Transplant Disorder

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Opioid consumption

  from day 0 to 30 days after the day of surgery

• Duration of hospitalisation

  From day = 0 day of the surgery to day to discharge day 15 maximum

• Quality of recovery

  1 month after surgery

• Patient satisfaction

  1 month after the surgery

• Quality of life (QOL) after donation

  1 months and 3 months after surgery

Study Arms (2)

standard of care

NO INTERVENTION

Peri-operative analgesia by opioids

Peri operative regional analgesia

EXPERIMENTAL

Peri-operative analgesia by Continuous bilateral Erector Spinae Catheters

Procedure: Erector spinae plane block

Interventions

Erector spinae plane block PROCEDURE

Insertion of bilateral catheters in the intersfacia space of erector spinae muscle

Peri operative regional analgesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vinmec Healthcare System: lead

Study Sites (1)

VinMec INternational hospital

Hanoi, 100000, Vietnam

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of anesthesia and pain management - Anesthesiologist MD

Model Details: Randomized controlled prospective trial

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 30, 2020
• Study Start: November 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: February 25, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)