Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 5:45 PM
Study NCT ID:
NCT05218733
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-01', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time for requirement of first rescue analgesic (min)', 'timeFrame': '24 hours postoperatively', 'description': 'The time for requirement of first rescue analgesic (min)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '40047853', 'type': 'DERIVED', 'citation': 'Ashoor TM, Esmat IM, Algendy MA, Mohamed NR, Talaat SM, Rabie AH, Elsayed AM. Comparison of the postoperative analgesic efficacy of the ultrasound-guided erector spinae plane block and intrathecal morphine in patients undergoing total abdominal hysterectomy under general anesthesia: a randomized controlled trial. J Anesth. 2025 Apr;39(2):299-310. doi: 10.1007/s00540-025-03466-1. Epub 2025 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed for many years and extensively used for pain management following abdominal surgeries such as laparotomies and appendicectomies. Erector Spinae Plane Block (ESPB)-first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries. Intrathecal opioid administration is an attractive analgesic technique since the opioid is injected directly into the cerebrospinal fluid, close to the structures of the central nervous system where the opioid acts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index (BMI) 25 to 35kg/m².\n* American Society of Anesthesiologist (ASA) physical status I or II.\n\nExclusion Criteria:\n\n* patient's refusal\n* Altered mental status\n* Known allergy to study drugs (bupivacaine or morphine)\n* Local infection at site of puncture.\n* Known case with any pulmonary disease\n* Known case with Obstructive sleep apnea (OSA)\n* Coagulopathy and /or thrombocytopenia\n* Chronic pain\n* Severe hepatic or kidney impairment"}, 'identificationModule': {'nctId': 'NCT05218733', 'briefTitle': 'Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Comparison Between Ultrasound Guided Erector Spinae Plane Block and Intrathecal Morphine', 'orgStudyIdInfo': {'id': 'IRB 00006379//31-1-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'G1 Group: (Erector Spinae Plane Block (ESPB) Group)', 'interventionNames': ['Procedure: Ultrasound Guided Erector Spinae Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'G2 Group: (Intra thecal morphine (ITM) Group)', 'interventionNames': ['Drug: Intra thecal morphine.']}, {'type': 'OTHER', 'label': 'G3 Group: (Control Group)', 'interventionNames': ['Drug: General anesthesia using intravenous fentanyl (1µgm/kg)']}], 'interventions': [{'name': 'Ultrasound Guided Erector Spinae Plane Block', 'type': 'PROCEDURE', 'description': 'General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive bilateral ultrasound-guided ESPB by the an experienced anesthetist in US regional blocks, with each block 20 mL of bupivacaine 0.25%', 'armGroupLabels': ['G1 Group: (Erector Spinae Plane Block (ESPB) Group)']}, {'name': 'Intra thecal morphine.', 'type': 'DRUG', 'description': 'General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive intra thecal morphine with spinal needle 25G, 3 ml containing 300 ug preservative free morphine', 'armGroupLabels': ['G2 Group: (Intra thecal morphine (ITM) Group)']}, {'name': 'General anesthesia using intravenous fentanyl (1µgm/kg)', 'type': 'DRUG', 'description': 'Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg)', 'armGroupLabels': ['G3 Group: (Control Group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain-Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain-shams University, Cairo, Egypt.', 'investigatorFullName': 'Ibrahim Mamdouh Esmat', 'investigatorAffiliation': 'Ain Shams University'}}}}