Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT05499234
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2022-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidural Tap in Labor Analgesia FOR LABOR ANALGESIA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008614', 'term': 'Meperidine'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and the medical staff administrating epidural drugs will not be told about the concentration. Because volumes will be same, they would not predict which group.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-10', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change the need of bupivacaine for epidural analgesia.', 'timeFrame': 'In an hour', 'description': 'primary aim of this study is to achieve Numeric Pain Rating Scale scores equal to or below 4 via different bupivacaine concentrations. More than 4 is bad and unacceptable'}], 'secondaryOutcomes': [{'measure': 'Complication comparison', 'timeFrame': '2 days', 'description': 'measure the number of treatment related complications and compare these measurements between the groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['labor analgesia', 'dural tap', 'concentration'], 'conditions': ['Labor Pain']}, 'referencesModule': {'references': [{'pmid': '41299385', 'type': 'DERIVED', 'citation': 'Ucar FP, Danisan HG, Omur B, Alici HA, Karaaslan P. Effects of different bupivacaine concentrations with dural puncture epidural technique for labor analgesia: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Nov 26;25(1):590. doi: 10.1186/s12871-025-03486-0.'}]}, 'descriptionModule': {'briefSummary': 'The dural epidural tap method is performed by creating a dural perforation with a spinal needle placed through epidural needle, followed by placement of a catheter into the epidural space. No medications are administered through spinal needle. This prospective, randomized study includes 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery.In the first group, 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution and in the second group, 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution was administered as the first dose through the epidural catheter. Then, the visual analog scale (VAS) score was aimed to be below 4 in both groups.', 'detailedDescription': 'This prospective, randomized study includes 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery. Participants with pregnancy-related diseases (such as gestational hypertension, gestational diabetes, preeclampsia) and contraindications for neuraxial block (infection, coagulation disorder, severe hypovolemia, sepsis, neurological deficit, cardiac valve stenosis or hypertrophic obstructive cardiomyopathy) will be excluded from the study. Women with fetal malpresentation and fetal anomaly will also be excluded.\n\nParticipants will randomly be divided into 2 equal groups. Immediately before epidural placement, subjects will be marked a VAS score during an active contraction. All subjects will have an intravenous catheter placed and be monitored with NST, noninvasive blood pressure and pulse oximetry.\n\nThe epidural space will be identified by a loss of resistance technique to saline. CSF flow will be observed at L3-L4 or L4-L5 level by puncturing the dura with a 27 G needle before inserting the epidural catheter. A combined spinal epidural set with 18 G Tuohy needle will be used in both groups. In the first group, 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution and in the second group, 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution will be administered as the first dose through the epidural catheter. Then, the visual analog scale (VAS) score will be aimed to be below 4 in both groups. Patients with a VAS score of 4 or higher 15 minutes after the first dose received, an additional 10 mL dose of the same solution will be given. An additional 10 mL dose also will be administered when the VAS score is 4 or higher until crowning.\n\nBefore the epidural catheter placed; age, weight, height, blood pressure of the participants, gestational week, use of oxytocin during delivery, cervical dilatation amount before the procedure and fetal heart rate will be recorded. After each dose of administration, whether maternal hypotension, fetal bradycardia, pruritus, nausea-vomiting or motor block development will be monitored. The total amount of drug administered through the epidural catheter, the time between applications, and the number of bolus doses administered will also be recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA II primigravid women\n* with cervical dilatation between 4-6 cm, demanding epidural analgesia during spontaneous vaginal delivery\n\nExclusion Criteria:\n\n* Participants with pregnancy-related diseases\n\n * gestational hypertension\n * gestational diabetes\n * preeclampsia/ celmpsia\n* contraindications for neuraxial block\n\n * infection\n * coagulation disorders\n * severe hypovolemia\n * sepsis\n * neurological deficit\n * cardiac valve stenosis or hypertrophic obstructive cardiomyopathy\n* Women with fetal malpresentation and fetal anomaly'}, 'identificationModule': {'nctId': 'NCT05499234', 'briefTitle': 'Epidural Tap in Labor Analgesia FOR LABOR ANALGESIA', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Effects of Different Local Anesthetic Concentrations With Epidural Tap Method for Labor Analgesia', 'orgStudyIdInfo': {'id': 'KARAASLANP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High concentration', 'description': 'Epidural analgesia with 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution', 'interventionNames': ['Drug: Dolantin', 'Drug: Paracetamol']}, {'type': 'EXPERIMENTAL', 'label': 'Low concentration', 'description': 'Epidural analgesia with 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution', 'interventionNames': ['Drug: Dolantin', 'Drug: Paracetamol']}], 'interventions': [{'name': 'Dolantin', 'type': 'DRUG', 'otherNames': ['Meperidin'], 'description': 'If VAS score is more than 4 even after additional dose, use dolantin 1 mg/kg', 'armGroupLabels': ['High concentration', 'Low concentration']}, {'name': 'Paracetamol', 'type': 'DRUG', 'otherNames': ['Parol'], 'description': 'If VAS score is more than 4 even after dolantin 1 mg/kg, 10 mg/kg paracetamol IV', 'armGroupLabels': ['High concentration', 'Low concentration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34700', 'city': 'Istanbul', 'state': 'Bağcılar', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Pınar Uçar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}, {'name': 'Emine Uzunoğlu', 'role': 'STUDY_CHAIR', 'affiliation': 'Medipol University'}, {'name': 'Pelin Karaaslan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medipol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pelin Karaaslan', 'investigatorAffiliation': 'Medipol University'}}}}