Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-22 @ 12:09 PM
Study NCT ID:
NCT06764667
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-01', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Hour 2, 6, 12, and 24', 'description': 'Postoperative pain measured with Numerical Rating Scale (NRS) during rest and movement.'}, {'measure': 'Opioid requirement', 'timeFrame': 'Hour 2, 6, 12, and 24', 'description': 'Morphine requirement on Patient-Controlled Analgesia (PCA).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quadratus lumborum block', 'Spinal anesthesia adjuvant', 'Laparoscopic donor nephrectomy', 'Perioperative pain management'], 'conditions': ['Laparoscopic Donor Nephrectomy', 'Perioperative Pain Management']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of spinal anesthesia adjuvant and quadratus lumborum block on the opioid requirement and perioperative pain on patients undergoing laparoscopic kidney transplant donor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-65 years undergoing laparoscopic donor nephrectomy\n* Patients with BMI ≤ 35 kg/m2\n* Patients with American Society of Anesthesiology (ASA) physical status 1-2\n* Patients who are willing to participate in this study\n\nExclusion Criteria:\n\n* Cardiovascular disease (uncontrolled stage 2 hypertension, heart failure, arrhytmia)\n* Recent onset cerebrovascular diseasae of \\< 3 months\n* Infection on spinal site\n* Coagulopathy\n* Elevated intracranial pressure\n* Severe renal or liver dysfunction\n* Valvular heart disease or atrioventricular block'}, 'identificationModule': {'nctId': 'NCT06764667', 'briefTitle': 'Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Quadratus lumborum block', 'description': 'Patients in this arm will receive quadratus lumborum block with 20-30 ml of 0.25% Bupivacaine after induction of anesthesia and after operation.', 'interventionNames': ['Procedure: Quadratus Lumborum Block (QLB)', 'Procedure: General Anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Spinal anesthesia adjuvant', 'description': 'Patients in this arm will receive 10 mg 0.5% hyperbaric Bupivacaine, 100 mcg Morphine, 100 mcg Sulfas Atropine, and 0.9% normal saline to total volume of 4 ml before induction of anesthesia.', 'interventionNames': ['Procedure: Spinal anesthesia adjuvant', 'Procedure: General Anesthesia']}], 'interventions': [{'name': 'Spinal anesthesia adjuvant', 'type': 'PROCEDURE', 'description': 'Patients in this arm will receive 10 mg 0.5% hyperbaric Bupivacaine, 100 mcg Morphine, 100 mcg Sulfas Atropine, and 0.9% normal saline to total volume of 4 ml before induction of anesthesia.', 'armGroupLabels': ['Spinal anesthesia adjuvant']}, {'name': 'Quadratus Lumborum Block (QLB)', 'type': 'PROCEDURE', 'description': 'Patients in this arm will receive quadratus lumborum block with 20-30 ml of 0.25% Bupivacaine after induction of anesthesia and after operation.', 'armGroupLabels': ['Quadratus lumborum block']}, {'name': 'General Anesthesia', 'type': 'PROCEDURE', 'description': 'The subject will undergo preoxygenation with 100% oxygen for 3 minutes. Following preoxygenation, anesthesia induction will be performed using lidocaine at a dose of 1.5 mg/kg, fentanyl at 1.5 mcg/kg, and propofol at 2.0 mg/kg. Once the subject is adequately sedated, baseline neuromuscular monitoring using the train-of-four (TOF) technique will be conducted, followed by the administration of rocuronium at a dose of 0.8 mg/kg. Endotracheal intubation will be performed using direct laryngoscopy once the TOF value reaches 0, utilizing an appropriately sized endotracheal tube (ETT). Ten milligrams of intravenous dexamethasone is administered after induction.', 'armGroupLabels': ['Quadratus lumborum block', 'Spinal anesthesia adjuvant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Dita Aditianingsih, Prof.', 'role': 'CONTACT', 'email': 'ditaaditiaa@gmail.com', 'phone': '+628151819244'}, {'role': 'CONTACT', 'email': 'ditaaditiaa@gmail.com'}, {'name': 'Alfan Mahdi Nugroho, dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dita Aditianingsih, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Muncieto Andreas, dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'RSUP dr. Cipto Mangunkusumo', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Dita Aditianingsih, Prof.', 'role': 'CONTACT', 'email': 'ditaaditiaa@gmail.com', 'phone': '+628151819244'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. dr. Dita Aditianingsih, Sp.An-TI., Subsp.T.I.(K).', 'investigatorFullName': 'Dita Aditianingsih', 'investigatorAffiliation': 'Indonesia University'}}}}