Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-01 @ 2:08 PM
Study NCT ID:
NCT07037992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Quadratus Lumborum (QL) Block on the Incidence of Chronic Neuropathic Pain After Retroperitoneal Laparoscopic Donor Nephrectomy: A Study on Neuroinflammation and Neurophysiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-05-26', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropathic Pain Incidence: Neuropathic Pain in 4 Questionnaire', 'timeFrame': '3 months after intervention', 'description': 'Pain that develops after a surgical procedure in the area of surgery and its radiation, persists for at least 3 months after surgery, other causes of pain (e.g. infection and history of malignancy) or pre-existing pain have been excluded.\n\nTotal score: 10 Score ≤ 4 = no pain developed Score ≥ 4 = pain developed'}, {'measure': 'Neuromodulation Parameter: Degree of functional interference using Behavioral Pain Interference (BPI)', 'timeFrame': 'At 3 months after intervention', 'description': 'The degree of pain that develops after a surgical procedure in the area of surgery and its radiation, persisting for at least 3 months after surgery, other causes of pain (eg infection and history of malignancy) or pre-existing pain have been excluded.\n\nBehavioral Pain Interference (BPI) questionnaire based on the average of questions 4, 5, and 6\n\n1. Mild (NRS 1-3)\n2. Moderate (NRS 4-6)\n3. Severe (NRS 7-10)'}, {'measure': 'Chronic Pain Severity: Leeds Assesment of neuropathic symptoms and sign (LANSS) scale', 'timeFrame': 'At 3 months after intervention', 'description': 'A measuring tool used to assess neuropathic pain and provides information to differentiate nociceptive pain from neuropathic pain.\n\nTotal score: 24 \\<12: Not neuropathic \\>12: Neuropathic pain'}, {'measure': 'Neuroinflammation Parameter: Serum Concentration of Toll-like Receptor 4 (TLR4)', 'timeFrame': 'At 3 months after intervention', 'description': 'Transmembrane receptors in the innate immune system. Units: ng/mL'}, {'measure': 'Neuroinflammation Parameter: Serum Concentration of Calcitonin gene-related peptide (CGRP)', 'timeFrame': 'At 3 months after intervention', 'description': 'Neuropeptides that play a role in pain transmission and vasodilation Unit: pg/mL'}, {'measure': 'Neuroinflammation Parameter: Serum Concentration of Nerve Growth Factor (NGF)', 'timeFrame': 'At 3 months after intervention', 'description': 'Neurotrophic factors that play a role in promoting the growth and survival of sensory neurons Unit: pg/mL'}, {'measure': 'Neurophysiology Parameter: Mechanical Detection Threshold (MDt)', 'timeFrame': 'At 3 months after intervention', 'description': 'Measures the minimum force needed for a person to perceive a light mechanical stimulus, tested using von Frey filaments. Skin contact test for 2 seconds using 1 set of von Frey filaments. The examination is performed in m. trapezius.\n\nUnit: mN Lower result means: higher sensitivity (normal or hypersensitivity) Higher result means: Reduced sensitivity, could indicate hypoesthesia or nerve damage'}, {'measure': 'Neurophysiology: Mechanical Pain Threshold (MPt)', 'timeFrame': 'At 3 months after intervention', 'description': 'Accurate measurement of pain threshold. Skin contact test using repeated pinpricks at the same location. Comparative assessment of initial pain scale with pain scale after repeated stimulation. Examination is performed at m. trapezius.\n\nUnit: Numerical Rating Scale (NRS) from 1 to 10 Lower NRS: higher sensitivity to pain Higher NRS: lower sensitivity to pain'}, {'measure': 'Neurophysiology Parameter: Pressure Pain Threshold (PPt)', 'timeFrame': 'At 3 months after intervention', 'description': 'Pain tolerance examination. Pressure assessment in kgf/cm2 units where the patient complains of pain according to the stimulus given. The examination is carried out in m. trapezius Units: kgf/cm2.\n\nLower PPT: Increased pain sensitivity Higher PPT: Decreased pain sensitivity'}, {'measure': 'Neurophysiology Parameter: Mechanical Temporal Summation of Pain (MTSP)', 'timeFrame': 'At 3 months after intervention', 'description': 'Evaluates central sensitization by applying repeated light mechanical stimuli and rating how pain builds up over time.\n\nPressure assessment in kgf/cm2 units where the patient complains of pain according to the stimulus given. The examination is carried out in m. trapezius.\n\nUnits: Verbal Numeric Scale (VNS) from 1 to 10 Higher MTSP score: Indicates central sensitization Lower MTSP score: Normal pain processing'}, {'measure': 'Neuromodulation Parameter: Serum Concentration of beta-Endorfin', 'timeFrame': 'At 3 months after intervention', 'description': 'Neuropeptide produced in the anterior pituitary and brain, as an endogenous opioid.\n\nUnits: pg/mL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Living Kidney Donor', 'Quadratus Lumborum Block', 'Laparoscopic Donor Nephrectomy']}, 'descriptionModule': {'briefSummary': 'To analyze the relationship of anterior subcostal quadratus lumborum (QL) block compared with control block on the incidence of chronic neuropathic pain at three months post-laparoscopic retroperitoneal living kidney donor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nLiving kidney donor candidate patients aged 18-65 years Patients with ASA physical status assessment 1-3 Patients are willing to be research subjects.\n\nExclusion Criteria:\n\n* The patient was known to have a history of chronic non-cancer pain and cancer pain.\n\nThe patient had a history of preoperative laparoscopic kidney donor surgery.'}, 'identificationModule': {'nctId': 'NCT07037992', 'briefTitle': 'The Effect of Quadratus Lumborum (QL) Block on the Incidence of Chronic Neuropathic Pain After Retroperitoneal Laparoscopic Donor Nephrectomy: A Study on Neuroinflammation and Neurophysiology', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Effect of Subcostal Anterior Quadratus Lumborum Block on the Incidence of Chronic Neuropathic Pain After Retroperitoneal Laparoscopic Donor Nephrectomy: A Study on Neuroinflammation and Neurophysiology', 'orgStudyIdInfo': {'id': 'QLChronicNeuropathicPostOpPain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadratus Lumborum Block', 'interventionNames': ['Drug: injection of local anesthesia solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Quadratus Lumborum Sham Block', 'interventionNames': ['Drug: Injection of normal saline']}], 'interventions': [{'name': 'injection of local anesthesia solution', 'type': 'DRUG', 'description': 'Injection of 30 mL local anesthetic solution bupivacaine 0.25%', 'armGroupLabels': ['Quadratus Lumborum Block']}, {'name': 'Injection of normal saline', 'type': 'DRUG', 'description': 'Injection of 30 mL normal saline Natrium Chloride (NaCl) 0.9%', 'armGroupLabels': ['Quadratus Lumborum Sham Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'contacts': [{'name': 'Raden B Sukmono', 'role': 'CONTACT', 'email': 'Raden.besthadi01@ui.ac.id', 'phone': '+62129508625'}], 'facility': 'RSUPN Cipto Mangunkusumo', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Raden B Sukmono', 'role': 'CONTACT', 'email': 'Raden.besthadi01@ui.ac.id', 'phone': '+628129508625'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Raden Besthadi Sukmono', 'investigatorAffiliation': 'Indonesia University'}}}}