Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-25 @ 12:56 AM
Study NCT ID:
NCT06008002
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2023-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, single-blind, observational study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2023-08-16', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS', 'timeFrame': 'Postoperative 24 hours', 'description': 'The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"'}], 'secondaryOutcomes': [{'measure': 'tramadol consumption', 'timeFrame': 'Postoperative 24 hours'}, {'measure': 'side effect profile scores', 'timeFrame': 'Postoperative 24 hours', 'description': '1\\. Nausea and vomiting scale (nausea-vomiting scale (NVS):\n\n1. No nausea is present,\n2. Mild nausea is present.\n3. Severe nausea is present.\n4. Vomiting is present) In case of a NVS score of \\>3, an anti-emetic drug was administered.'}, {'measure': 'additional analgesic use', 'timeFrame': 'Postoperative 24 hours', 'description': 'additional analgesic use'}, {'measure': 'pinprick test', 'timeFrame': 'Postoperative 24 hours', 'description': 'The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients.\n\nWith the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.'}, {'measure': 'Ramsay Sedation Scale', 'timeFrame': 'Postoperative 24 hours', 'description': 'Ramsay Sedation Scale (RSS) :\n\n1. Anxiety, agitation are present;\n2. Cooperated,awake;\n3. Sedated , response to commands;\n4. Sleepy, immediately awoken by auditory stimulus or glabella tap;\n5. Sleepy, deep response to auditory stimulus or glabella tap and\n6. Sleepy, no response to auditory stimulus or glabella tap )'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Laparoscopic Cholecystectomy', 'Regional Anesthesia']}, 'descriptionModule': {'briefSummary': 'Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.', 'detailedDescription': 'In our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laparoscopic cholecystectomy surgery\n* Patients with ASA (American Society of Anaesthetists) scores I and III will be included.\n\nExclusion Criteria:\n\n* Uncontrolled Arterial Hypertension\n* Uncontrolled Diabetes Mellitus,\n* Mental retardation ,\n* Antidepressant use\n* Metabolic disorders,\n* Bleeding diathesis\n* Patients with a body mass index above 30.'}, 'identificationModule': {'nctId': 'NCT06008002', 'briefTitle': 'Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study', 'orgStudyIdInfo': {'id': '2023-3/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group M', 'description': 'ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block', 'interventionNames': ['Procedure: M-TAPA block', 'Drug: Tramadol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group E', 'description': 'Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block', 'interventionNames': ['Procedure: EXORA block', 'Drug: Tramadol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group P', 'description': 'Patient-controlled analgesia with tramadol', 'interventionNames': ['Drug: Tramadol']}], 'interventions': [{'name': 'M-TAPA block', 'type': 'PROCEDURE', 'description': 'ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed', 'armGroupLabels': ['Group M']}, {'name': 'EXORA block', 'type': 'PROCEDURE', 'description': 'Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed', 'armGroupLabels': ['Group E']}, {'name': 'Tramadol', 'type': 'DRUG', 'description': '400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.', 'armGroupLabels': ['Group E', 'Group M', 'Group P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16110', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Korgün Ökmen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Korgün Ökmen', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}