Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04570969
Status:
UNKNOWN
Last Update Posted:
2022-11-15
First Post:
2020-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled prospective trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-11', 'studyFirstSubmitDate': '2020-09-20', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of pain relief at rest', 'timeFrame': 'from day 0 = day of surgery to day 180', 'description': 'Visual analgesic score at rest'}, {'measure': 'quality of pain relief at mouvement', 'timeFrame': 'from day 0 = day of surgery to day 180', 'description': 'Visual analgesic score at mouvement'}], 'secondaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'from day 0 to 30 days after the day of surgery', 'description': 'Total dose of opioids required'}, {'measure': 'Duration of hospitalisation', 'timeFrame': 'From day = 0 day of the surgery to day to discharge day 15 maximum', 'description': 'Duration of hospitalisation'}, {'measure': 'Quality of recovery', 'timeFrame': '1 month after surgery', 'description': 'Score based on Table quality of recovery including 15 criteria from 0 to 10 each ) = poor 10 = excellent poor recovery scale 0 to 150'}, {'measure': 'Patient satisfaction', 'timeFrame': '1 month after the surgery', 'description': 'index from 0 not satisfy to 10 extremely satisfied'}, {'measure': 'Quality of life (QOL) after donation', 'timeFrame': '1 months and 3 months after surgery', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant Disorder']}, 'descriptionModule': {'briefSummary': '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.\n\nTo donate a part of liver is a beautiful gift reason why the pain relief must be improved.\n\nMeta-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.\n\nErector 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', 'detailedDescription': '1. Goals:\n\n Compare quality of pain relief and quality of life between bilateral ESP bilateral catheters Vs Opioid analgesia in donor patients for liver donation.\n2. Methodology:\n\n • Selection criteria: Age \\> 18 years old Be volunteer to donate liver Agree to participate in the trial\n\n • 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\n\n • Study design: Prospective Randomized Controlled Trial.\n\n Patients who agree to join the study will be randomized into 2 groups:\n\n 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)\n\n 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)\n3. Project outcomes:\n\n * Primary outcomes Quality of pain relief with opioid consumption\n * Secondary outcomes Duration of hospitalisation participants satisfaction Quality of recovery (QOR 16) Pain at 1 \\& 3 months rest and mobilization + QOL'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age more than 18 and less than 61\n* Be volunteer to donate liver\n* agree to participate to study and consent signed\n* Risk of americain society of anesthesiologists score ASA from 1 to 5 score ASA must be 1 only\n\nExclusion Criteria:\n\n* Use of chronic opioid before the surgery\n* A diagnosis of chronic pain condition\n* Contra indication to perform ESP catheter\n* allergy to local anesthestics\n* Depression or psychiatric diagnosis'}, 'identificationModule': {'nctId': 'NCT04570969', 'acronym': 'ESPLIVERDON', 'briefTitle': 'Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Vinmec Healthcare System'}, 'officialTitle': 'Improvement of Quality of Life After Live Liver Donation by ESP Peri Operative Analgesia', 'orgStudyIdInfo': {'id': 'VINMEC LT DON'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard of care', 'description': 'Peri-operative analgesia by opioids'}, {'type': 'EXPERIMENTAL', 'label': 'Peri operative regional analgesia', 'description': 'Peri-operative analgesia by Continuous bilateral Erector Spinae Catheters', 'interventionNames': ['Procedure: Erector spinae plane block']}], 'interventions': [{'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Insertion of bilateral catheters in the intersfacia space of erector spinae muscle', 'armGroupLabels': ['Peri operative regional analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Hanoi', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Philippe Macaire, MD', 'role': 'CONTACT', 'email': 'ph.macaire@gmail.com', 'phone': '0966103845'}], 'facility': 'VinMec INternational hospital', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vinmec Healthcare System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of anesthesia and pain management - Anesthesiologist MD', 'investigatorFullName': 'Philippe Macaire', 'investigatorAffiliation': 'Vinmec Healthcare System'}}}}