Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-21 @ 6:51 PM
Study NCT ID:
NCT06553495
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Analysis of Intertransverse Nerve Block and Paravertebral Nerve Block in Endoscopic Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of effective compressions of the analgesic pump within 24 hours after surgery', 'timeFrame': 'Within 24 hours after the operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the analgesic effect of intertransverse nerve block and paravertebral nerve block after endoscopic hepatectomy, evaluate its effectiveness and safety, and provide new ideas and clinical basis for postoperative pain management of liver surgery.', 'detailedDescription': 'This study was a prospective, double-blind, randomized controlled trial. Patients who were eligible for laparoscopic partial liver resection in our center were included, with intertransverse nerve block as the experimental group and paravertebral nerve block as the control group. Through the analysis of postoperative pain score 30min to 24h, the number of effective analgesic pump compressions within 24h, the amount of analgesic drugs used, complications and other data, To evaluate the efficacy and safety of intertransverse nerve block in patients undergoing laparoscopic partial liver resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:1:\n\n1.18-80 years old adult, BMI\\<27.9kg/m2\n\n2: 2. American Society of Anesthesiologists ASA Grade I-III\n\n3: 3. Patients with laparoscopic partial liver resection such as liver tumors\n\n4: 4. Willing to participate in this study and sign the informed consent form\n\n\\-\n\nExclusion Criteria:\n\n1. 1\\. The patient or family member refuses to sign the informed consent form\n2. 2\\. Blood coagulation dysfunction, local infection\n3. 3\\. Those who have communication, communication disorders or mental abnormalities\n4. 4\\. Patients with severe heart, pulmonary and renal insufficiency or patients with central system diseases\n5. 5\\. For any reason, it cannot be matched with the study or the researcher believes that it is not appropriate to be included in this experiment.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT06553495', 'briefTitle': 'A Comparative Analysis of Intertransverse Nerve Block and Paravertebral Nerve Block in Endoscopic Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'A Comparative Analysis of Intertransverse Nerve Block and Paravertebral Nerve Block in Endoscopic Hepatectomy', 'orgStudyIdInfo': {'id': '2024-098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intertransverse nerve block', 'description': 'To study the analgesic effect of intertransverse nerve block after endoscopic hepatectomy', 'interventionNames': ['Other: Nerve block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'paravertebral nerve block', 'description': 'To study the analgesic effect of paravertebral nerve block after endoscopic hepatectomy', 'interventionNames': ['Other: Nerve block']}], 'interventions': [{'name': 'Nerve block', 'type': 'OTHER', 'description': 'Analgesic effect of different nerve blocks', 'armGroupLabels': ['intertransverse nerve block', 'paravertebral nerve block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The Second Affiliated Hospital Of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jie Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': '临床教授', 'investigatorFullName': 'Jie Chen', 'investigatorAffiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}}}}