Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-21 @ 7:08 AM
Study NCT ID:
NCT05730751
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2023-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Could Intrathecal Fentanyl Prevent Shoulder Tip Pain (STP) During and After Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}, {'id': 'D002585', 'term': 'Cesarean Section'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-03', 'studyFirstSubmitDate': '2023-02-05', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of occurrence intraoperative and early postoperative shoulder tip pain anesthesia as a preventive analgesia for shoulder tips pain with Cesarean section.', 'timeFrame': 'intraoperative till 12 hours postoperative', 'description': 'comparing incidence of shoulder pain between the groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'Shoulder pain is a commonly observed, annoying and mostly neglected consequence of cesarean section and little is known as well as explored about intraoperative shoulder pain. This study will explore the factors precipitating shoulder pain during cesarean section, preventive analgesia and treatment modalities', 'detailedDescription': 'The most common surgery performed on women around the world is caesarean section. The majority of caesarean sections these days are carried out under regional analgesia, though some need to be carried out under general anesthesia, particularly in emergency situations or when there is a contraindication to the use of regional anesthesia. Benefits of spinal anesthesia include an awake mother at birth, minimizing or avoiding the risk of general anesthesia (aspiration, difficulty intubation, etc.) and minimal side effects to the newborn.\n\nShoulder tip pain (STP) is a usual complication after laparoscopy with the incidence reported varying between35% to 80%. Recent studies suggest that this type of pain is also seen after cesarean section Shoulder pain is commonly observed, but is largely ignored complication of caesarean section, and little is understood or studied regarding intraoperative shoulder pain.\n\nShoulder pain can be more excruciating in some patients than the pain from the surgical incision. This pain may be associated with diaphragmatic irritation/injury from local acidosis, the irritating effects of carbon dioxide during pneumoperitoneum, or stretching forces on the diaphragm. ( Although carbon dioxide is not used in cesarean compared to laparoscopic surgeries, stretching forces on the diaphragm during cesarean can be one of the causes of shoulder pain in these patients.\n\nIt is believed that seepage of blood or amniotic fluid into the abdomen accumulation during cesarean section and subdiaphragmatic may be the cause of STP. Retained blood clots in patients undergoing CS can induce diaphragmatic discomfort and stimulate the phrenic nerve. Peritoneal cleaning and visceral manipulation also may play a part.\n\nFentanyl is a commonly used lipophilic opioid for spinal anesthesia with relatively approved intraoperative anti-nociceptors effect.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'parturients undergoing LSCS', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I-II,\n* uncomplicated, singleton pregnancies of at least 36 weeks gestation.\n\nExclusion Criteria:\n\n* Cardiac, liver or renal disease\n* Allergy to amide local anesthetics\n* History of epilepsy or any other neurological problem\n* Any contraindication of regional anesthesia, or patient refusal\n* Intrauterine growth restriction or fetal compromise'}, 'identificationModule': {'nctId': 'NCT05730751', 'briefTitle': 'Could Intrathecal Fentanyl Prevent Shoulder Tip Pain (STP) During and After Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Could Intrathecal Fentanyl Prevent Shoulder Tip Pain (STP) During and After Caesarean Section', 'orgStudyIdInfo': {'id': 'FMASU R213/2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group F', 'description': 'The patients will receive 2.5 ml of hyperbaric bupivacaine 0.5 % and 25 µg fentanyl \\[6\\].', 'interventionNames': ['Procedure: spinal anesthesia', 'Procedure: caesarean section']}, {'label': 'Group C', 'description': 'The patients will receive 2.5 ml of hyperbaric bupivacaine 0.5 %', 'interventionNames': ['Procedure: spinal anesthesia', 'Procedure: caesarean section']}], 'interventions': [{'name': 'spinal anesthesia', 'type': 'PROCEDURE', 'description': 'spinal anesthesia', 'armGroupLabels': ['Group C', 'Group F']}, {'name': 'caesarean section', 'type': 'PROCEDURE', 'description': 'LSCS', 'armGroupLabels': ['Group C', 'Group F']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12245', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate proffesor', 'investigatorFullName': 'Adham Haggag', 'investigatorAffiliation': 'Ain Shams University'}}}}