Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT05186467
Status:
UNKNOWN
Last Update Posted:
2022-01-26
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain After Laparoscopy Results From the Incision, Manipulation of the Abdominal Organs, and Retained CO2(Back Pain)
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-02-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time for first dose of rescue analgesia', 'timeFrame': '8 hours', 'description': '1st time to feel pain'}, {'measure': 'total analgesic doses', 'timeFrame': '8 hours', 'description': 'total (ketorolac) analgesic consumption'}], 'secondaryOutcomes': [{'measure': 'post operative pain', 'timeFrame': '8 hours', 'description': 'The visual analog scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)'}, {'measure': 'sedation', 'timeFrame': '8 hours', 'description': '4 points sedation scale: 0= alert and conscious\n\n1 =quietly awake 2= asleep but easily arousable 3= deep sleep'}, {'measure': 'adverse events', 'timeFrame': '8 hours', 'description': 'side effects'}, {'measure': 'serum mgso4 level', 'timeFrame': '2 hours', 'description': 'serum level of mgso4 at end of operation and after 2 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mgso4,laparoscopy ,intraperitoneal'], 'conditions': ['Post Operative Pain, Acute']}, 'descriptionModule': {'briefSummary': 'Postoperative pain after laparoscopy may be localized pain resulting from incision due to many (two or three) punctures (somatic pain) or due to manipulation of the intra-abdominal organs as ovaries, uterus, omentum, and intestine (visceral pain) or shoulder and back pain caused by retained CO2 in the peritoneal cavity with its irritation effect on the diaphragm.Patients will be divided into two groups:\n\nIntraperitoneal (IP) group (20 patients):They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.\n\nIntravenous (IV) group (20 patients):They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n20-44 years old females, (ASA) class I-II\n\nExclusion Criteria:\n\n* Patient refusal\n* Allergy to MgSO4\n* Atrio-ventricular conduction abnormalities\n* Drug abuse\n* Renal or hepatic or cardiovascular dysfunction\n* Prior long-term treatment with calcium channel blockers or magnesium'}, 'identificationModule': {'nctId': 'NCT05186467', 'briefTitle': 'Pain After Laparoscopy Results From the Incision, Manipulation of the Abdominal Organs, and Retained CO2(Back Pain)', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Comparing the Analgesic Effect of Intraperitoneal and Intravenous Magnesium Sulphate in Diagnostic Gynecological Laparoscopy', 'orgStudyIdInfo': {'id': '2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intraperitoneal magnesium sulfate (IP) group', 'description': 'They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then an intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.', 'interventionNames': ['Drug: intraperitoneal Magnesium sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous magnesium sulfate (IV) group', 'description': 'They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy.', 'interventionNames': ['Drug: intravenous magnesium sulfate']}], 'interventions': [{'name': 'intraperitoneal Magnesium sulfate', 'type': 'DRUG', 'description': 'Intraperitoneal (IP) group will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.', 'armGroupLabels': ['Intraperitoneal magnesium sulfate (IP) group']}, {'name': 'intravenous magnesium sulfate', 'type': 'DRUG', 'description': 'Intravenous (IV) group will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy.', 'armGroupLabels': ['Intravenous magnesium sulfate (IV) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52514', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Fouad Soliman', 'role': 'CONTACT', 'email': 'fouad_soliman@med.sohag.edu.eg', 'phone': '01113815186'}], 'facility': 'Fouad Soliman', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Fouad Soliman, lecturer', 'role': 'CONTACT', 'email': 'fouad_soliman@med.sohag.edu.eg', 'phone': '01113815186'}, {'name': 'Soliman', 'role': 'CONTACT', 'email': 'fouad_soliman@med.sohag.edu.eg', 'phone': '01113815186'}], 'overallOfficials': [{'name': 'Fouad Soliman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia and ICU', 'investigatorFullName': 'Fouad Soliman', 'investigatorAffiliation': 'Sohag University'}}}}