Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT06346860
Status:
COMPLETED
Last Update Posted:
2025-05-01
First Post:
2024-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device', 'timeFrame': '48 hours', 'description': 'Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous morphine consumption will be recorded via PCA device, then it will be documented in mg/kg units.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain assessment with Numeric Rating Scale (NRS)', 'timeFrame': '48 hours', 'description': 'In a Numerical Rating Scale (NRS), patients are asked to choose the number'}, {'measure': 'Comparison of the frequency of treatment related complications', 'timeFrame': '48 hours', 'description': 'Bradycardia, hypotension, sedation, respiratory depression, urinary retention, itching, need for rescue analgesics.'}, {'measure': 'Participant satisfaction', 'timeFrame': '48 hours', 'description': 'Whether the patient is very pleased/ satisfied/ unsatisfied/ complainant with the pain treatment will be recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intrathecal morphine', 'Modified Thoracoabdominal Nerve Block Through Perichondral Approach'], 'conditions': ['Opioid Use', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Patients undergoing major abdominal surgery\n\nExclusion Criteria:\n\n* Patients with solid organ dysfunction\n* Patients who receive opioid or corticosteroid medication prior to surgery\n* Patients with bleeding diathesis\n* Patients with psychiatric disorders\n* Patients who can not be contacted after surgery'}, 'identificationModule': {'nctId': 'NCT06346860', 'briefTitle': 'Comparing Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Comparing Postoperative Analgesic Effects of Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery', 'orgStudyIdInfo': {'id': '09.2024.241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and PCA', 'description': 'Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and Intravenous Patient Controlled Analgesia', 'interventionNames': ['Procedure: Regional Block Comparison']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intrathecal Morphine and Intravenous Patient Controlled Analgesia', 'description': 'Intrathecal Morphine 200 mcg and Intravenous Patient Controlled Analgesia (1 mg/ml morphine, 1 cc bolus, 7 min. locked', 'interventionNames': ['Procedure: Regional Block Comparison']}], 'interventions': [{'name': 'Regional Block Comparison', 'type': 'PROCEDURE', 'description': 'Comparing postoperative pain and opioid consumption in groups', 'armGroupLabels': ['Intrathecal Morphine and Intravenous Patient Controlled Analgesia', 'Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and PCA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University School of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Beliz Bilgili', 'investigatorAffiliation': 'Marmara University'}}}}