Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT05271760
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Analgesia as Fast Track Painless Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2022-02-27', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of degree of labor pain after administration of analgesia (spinal, epidural and combined spinal-epidural', 'timeFrame': '6 months', 'description': 'By using Visual Analogue score (VAS score)'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '6 months', 'description': 'By patient satisfaction survey'}, {'measure': 'Complications of technique', 'timeFrame': '6 months', 'description': 'Incidence or frequency of any complication that may occur'}, {'measure': 'Cost benefits', 'timeFrame': '6 months', 'description': 'Cost of techniques(how much the cost of spinal kits in relation to the cost of epidural and combined spinal epidural kits in Saudi Riyal'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Pain', 'Pain, Postoperative', 'Pain, Acute']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective, randomized, and controlled trial was to compare the efficacy of single-shot spinal analgesia to typical conventional treatments (continuous epidural analgesia and spinal-epidural combination) in reducing labor pain, particularly in multiparous women.\n\nwe will enroll in each of the three groups(S group= single-shot Spinal group), (E group= Continuous Epidural), and (C group = combined spinal-epidural) women in advanced active labor and fulfill inclusion criteria.', 'detailedDescription': 'Patients in active labor with cervical dilation between 4-5 cm multiparous with normal fetal heart rate (FHR) tracings were considered. After the request for analgesia, each patient was randomized, using a computer-generated randomization table, to receive spinal analgesia, continuous epidural analgesia, or combined spinal-epidural analgesia. Under A complete aseptic condition in a sitting position, all techniques are performed in the Labor and delivery room. All parturients are categorized into three groups as follows:\n\nGroup S (spinal n=40) The intrathecal medication included 1ml of 0.5% heavy bupivacaine (5 mg) and 25 μg fentanyl, CSF barbotage will do to reach a total volume of 2 ml. Group E (continuous Epidural n=40): Epidural analgesia is performed using a 16-gauge Tuohy epidural needle using a loss-of-resistance- to-saline technique, upon feeling the loss of resistance an epidural catheter will be introduced cranially through the needle for 5 cm in the L3-L4 epidural space, after negative aspiration for blood or spinal fluid a test dose of 3 ml lidocaine 1.5% with epinephrine 1:200000 will be given via inserted catheter, 10 ml of 0.125 % bupivacaine and 2ug/ml fentanyl will be injected as a loading dose then the solution will infuse in a rate of 6 -14 ml/h.\n\nGroup C (Combined spinal-epidural n=40) Epidural analgesia is performed using a combined spinal-epidural set. using a loss-of-resistance- to-saline technique, upon feeling the loss of resistance, once epidural space will be detected, 27 G Whitacre spinal needle inserted through Touhy epidural needle, intrathecal injection of 1ml of 0.5% heavy bupivacaine (5 mg) and 25 μg fentanyl, CSF barbotage will do to reach a total volume of 2 ml. Then an epidural catheter will be introduced cranially through the needle for 5 cm in the L3-L4 epidural space, after negative aspiration for blood or spinal fluid.\n\n10 ml of 0.125 % bupivacaine and 2ug/ml fentanyl will be injected as a loading dose then the solution will infuse at a rate of 6 -14 ml/h if needed.\n\nThen, the parturients will be placed in the supine position with left lateral displacement produced by placing a wedge under the right hip to prevent aortocaval compression and hypotension. Supplemental oxygen will be applied using a nasal cannula (2-4 L/min).\n\nEach patient will receive at least 10 mL/kg Ringer lactate solution. All patients will be monitored before the procedures and every 5 minutes after for 30 for any hemodynamic instability and fetal viability The duration of analgesia is defined as the time from the injection of the local anesthetic solution until the patient requested an additional analgesic dose.\n\nAfter the administration of the anesthetic solution, each patient will be evaluated by an investigator every 5 min for the first 15 min. Patients are assessed every 15 min until additional analgesia is requested.\n\nPatient appraisal included Assessment of vital signs (blood pressure, heart rate, respiratory rate) and completion by the patient of a 10-cm linear visual analog scale (VAS) for pain (0= no pain; 10 = severe pain). Patients will be excluded from the final data analysis if the patients reported pain VAS \\>8 up to 15 min after the injection of the anesthetic solution. At the same time intervals, somnolence will be evaluated using a four-point ordinal scale in which 0= wide awake, 1= drowsy, 2= arousable, 3 = non-arousable, the Motor blockade will be assessed using the four-point Bromage scale. The upper level of loss of sensation to ice will be assessed in the mid-clavicular line 15 min after the injection of the anesthetic solution. Time 2 segment regressions will be assessed. Side effects such as Pruritus, nausea, or vomiting Patient and obstetrician satisfaction. All patients have continuous electronic FHR monitoring throughout labor. Any FHR abnormalities, identified by the obstetric team, will be documented. After labor, the baby will be assessed, and the mother will be nursed in a post-anesthetic care unit (PACU ) and observed if there is nausea, vomiting, dyspnea, hemodynamic changes (hypotension and reflex tachycardia), and Spo2 changes will be recorded too, also patient will be evaluated for any Sensory or motor complication. The purpose of this study is to investigate the safety and effectiveness of single-dose spinal or epidural analgesia to control labor pain in properly-selected multiparous women in a tertiary referral maternity hospital.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The required sample size was n= 27 in each group (Totally of 81). Therefore, we will enroll 102 patients to account for the dropout rate of 20%.', 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiparous parturients\n* ASA physical status II,\n* Full-term singleton fetus\n* Vertex presentation requesting analgesia during labor.\n* Active labor, 4 to 5 cm dilated cervix\n\nExclusion Criteria:\n\n* Patients with contraindications to regional anesthesia\n* Complicated pregnancies\n* Primiparous parturients\n* Diagnosed fetal abnormalities\n* Allergy to the study medications\n* INR \\>1.3, and or platelets count \\<100,000'}, 'identificationModule': {'nctId': 'NCT05271760', 'briefTitle': 'Spinal Analgesia as Fast Track Painless Labor', 'organization': {'class': 'OTHER', 'fullName': 'Prince Sattam Bin Abdulaziz University'}, 'officialTitle': 'Fast Track Painless Labor: New Approaches for Pain-free Delivery in Multiparous Women', 'orgStudyIdInfo': {'id': 'REC-HSD-64-2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'S group', 'description': 'Single-shot Spinal group', 'interventionNames': ['Procedure: Single-shot spinal analgesia']}, {'label': 'E group', 'description': 'Continuous Epidural', 'interventionNames': ['Procedure: Continuous epidural analgesia']}, {'label': 'C group', 'description': 'combined spinal-epidural', 'interventionNames': ['Procedure: Combined spinal-epidural analgesia']}], 'interventions': [{'name': 'Single-shot spinal analgesia', 'type': 'PROCEDURE', 'description': 'The intrathecal medication included 1ml of 0.5% heavy bupivacaine (5 mg) and 25 μg fentanyl, CSF barbotage will do to reach a total volume of 2 ml', 'armGroupLabels': ['S group']}, {'name': 'Continuous epidural analgesia', 'type': 'PROCEDURE', 'description': 'Epidural analgesia is performed using a 16-gauge Tuohy epidural needle using a loss-of-resistance- to-saline technique, upon feeling the loss of resistance an epidural catheter will be introduced cranially through the needle for 5 cm in the L3-L4 epidural space, after negative aspiration for blood or spinal fluid a test dose of 3 ml lidocaine 1.5% with epinephrine 1:200000 will be given via inserted catheter, 10 ml of 0.125 % bupivacaine and 2ug/ml fentanyl will be injected as a loading dose then the solution will infuse in a rate of 6 -14 ml/h.', 'armGroupLabels': ['E group']}, {'name': 'Combined spinal-epidural analgesia', 'type': 'PROCEDURE', 'description': 'Epidural analgesia is performed using a combined spinal-epidural set. using a loss-of-resistance- to-saline technique, upon feeling the loss of resistance, once epidural space will be detected, 27 G Whitacre spinal needle inserted through Touhy epidural needle, intrathecal injection of 1ml of 0.5% heavy bupivacaine (5 mg) and 25 μg fentanyl, CSF barbotage will do to reach a total volume of 2 ml. Then an epidural catheter will be introduced cranially through the needle for 5 cm in the L3-L4 epidural space, after negative aspiration for blood or spinal fluid.\n\n10 ml of 0.125 % bupivacaine and 2ug/ml fentanyl will be injected as a loading dose then the solution will infuse at a rate of 6 -14 ml/h if needed.', 'armGroupLabels': ['C group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11942', 'city': 'Al Kharj', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'Prince Sattam bin Abdulaziz University', 'geoPoint': {'lat': 24.15541, 'lon': 47.33457}}], 'overallOfficials': [{'name': 'Ahmed Abodonya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prince Sattam Bin Abdulaziz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince Sattam Bin Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ahmed Abodonya', 'investigatorAffiliation': 'Prince Sattam Bin Abdulaziz University'}}}}