Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05338320
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2022-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia
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': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2022-04-14', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first requested rescue analgesia (Minutes).', 'timeFrame': 'First 24 hours after surgery.', 'description': 'Time to first requested rescue analgesia (Minutes).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. Ultrasound guided Erector Spinae Plane Block (ESPB) was first described in 2016.Recent case reports suggest a positive effect of ultrasound guided ESPB on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index (BMI) 25 to 35 kg/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* Severe hepatic or kidney impairment"}, 'identificationModule': {'nctId': 'NCT05338320', 'briefTitle': 'Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia: Ultrasound Guided Erector Spinae Plane Block Versus Intrathecal Morphine', 'orgStudyIdInfo': {'id': 'FMASU MD 102/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'General anesthesia and Ultrasound Guided Erector Spinae Plane Block', 'interventionNames': ['Procedure: Ultrasound Guided Erector Spinae Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General anesthesia and intrathecal morphine', 'interventionNames': ['Drug: Intrathecal morphine']}, {'type': 'OTHER', 'label': 'General anesthesia using intravenous fentanyl (1µg/kg)', 'interventionNames': ['Other: General anesthesia using intravenous fentanyl (1µg/kg)']}], 'interventions': [{'name': 'Ultrasound Guided Erector Spinae Plane Block', 'type': 'PROCEDURE', 'description': 'General anesthesia and Ultrasound Guided Erector Spinae Plane Block', 'armGroupLabels': ['General anesthesia and Ultrasound Guided Erector Spinae Plane Block']}, {'name': 'Intrathecal morphine', 'type': 'DRUG', 'description': 'General anesthesia and intrathecal morphine', 'armGroupLabels': ['General anesthesia and intrathecal morphine']}, {'name': 'General anesthesia using intravenous fentanyl (1µg/kg)', 'type': 'OTHER', 'description': 'General anesthesia using intravenous fentanyl (1µg/kg)', 'armGroupLabels': ['General anesthesia using intravenous fentanyl (1µg/kg)']}]}, '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'}}}}