Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-02 @ 3:04 AM
Study NCT ID:
NCT06371456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-14', 'studyFirstSubmitDate': '2024-04-14', 'studyFirstSubmitQcDate': '2024-04-14', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'appearance of the dew sign', 'timeFrame': 'immediately during aspiration of the epidural catheter', 'description': 'dew formation inside the outer portion of the epidural catheter near the patient'}], 'secondaryOutcomes': [{'measure': 'epidurogram', 'timeFrame': 'immediately after epidural catheter insertion', 'description': 'by using posteroanterior x-ray image after injection of radiopaque dye through the epidural catheter with appearance of distribution of the dye in the epidural space and may exit through the neuroforamina laterally'}, {'measure': 'visual analogue score', 'timeFrame': '20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%', 'description': 'making a handwritten mark on a 10 cm line that represents a continuum between "no pain" and "worst pain"'}, {'measure': 'mean blood pressure', 'timeFrame': '20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%', 'description': 'by non invasive monitor'}, {'measure': 'mean blood pressure', 'timeFrame': '30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%', 'description': 'by non invasive monitor'}, {'measure': 'heart rate', 'timeFrame': '20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%', 'description': 'by non invasive monitor'}, {'measure': 'heart rate', 'timeFrame': '30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%', 'description': 'by non invasive monitor'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Normal Delivery Pain']}, 'descriptionModule': {'briefSummary': 'Epidural anesthesia for pain control during normal vaginal delivery is a blind maneuver and so we need a confirmatory sign for being in the correct epidural space.\n\nLoss of resistance sign using air may guide us wrongly as it may occur if we entered into the paravertebral muscles or cavities in the interspinal ligaments.\n\nSo, additional confirmatory sign beside loss of resistance sign by air is strongly needed.\n\nWe noticed that after occurence of loss of resistance sign by air and insertion of the epidural catheter a dew was formed on the internal sides of the epidural catheter after aspiration to be sure that there are no blood or cerebrospinal fluid in the catheter.\n\nThis dew formation (Ramy sign) is characteristic for air in the epidural space when transferred from the warm epidural space (temperature about 38-39 celsius degree) to the colder aspect of the catheter outside the patient which nearly has the same operating room temperature (22 celsius degree).\n\nThis sign may be associated with correct placement and good function of the epidural catheter.', 'detailedDescription': 'parturient for normal vaginal delivery are examined for correct epidural catheter placement by loss of resistance technique by air, observation of the dew sign and epidurogram.\n\nVisual analogue score is used to test pain. blood pressure and heart rate after epidural injection will be monitored'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parturient for normal vaginal delivery\n* American society of anesthesiologists 2\n\nExclusion Criteria:\n\n* patients refusal\n* back infection\n* anticoagulant non stopped\n* platelets count less than 100000\n* international normalization ratio more than 1.4\n* severe cardiac or respiratory diseases\n* haemodynamics unstable patients'}, 'identificationModule': {'nctId': 'NCT06371456', 'briefTitle': 'A Non Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Anon Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery', 'orgStudyIdInfo': {'id': 'Ain Shams university 111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'epidural anesthesia', 'interventionNames': ['Procedure: epidural catheter placement']}], 'interventions': [{'name': 'epidural catheter placement', 'type': 'PROCEDURE', 'description': 'after sterilization of the back, local anesthesia injection (xylocaine 5 ml) at lumbar 4-5 level, then advancing the epidural needle till loss of resistance by air occurs and the epidural catheter inserted then aspiration through the catheter will be done to confirm that no accidental cerebrospinal fluid or blood are aspirated and to observe the dew sign inside the outer portion of the epidural catheter near the back of the patient', 'armGroupLabels': ['epidural anesthesia']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia', 'investigatorFullName': 'RAMY AHMED', 'investigatorAffiliation': 'Ain Shams University'}}}}