Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT06695520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-19
First Post:
2024-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perfusion Index in Caudal Epidural Anasthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-17', 'studyFirstSubmitDate': '2024-11-17', 'studyFirstSubmitQcDate': '2024-11-17', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in perfusion index.', 'timeFrame': 'baseline', 'description': 'measures the ratio of arterial blood flow (pulsatile flow) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and it is shown in percentage or absolute value'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perfusion Index'], 'conditions': ['Caudal Epidural Block']}, 'referencesModule': {'references': [{'pmid': '33447184', 'type': 'BACKGROUND', 'citation': 'Buono RD, Pascarella G, Costa F, Agro FE. The perfusion index could early predict a nerve block success: A preliminary report. Saudi J Anaesth. 2020 Oct-Dec;14(4):442-445. doi: 10.4103/sja.SJA_171_20. Epub 2020 Sep 24.'}, {'pmid': '28337460', 'type': 'BACKGROUND', 'citation': 'Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26.'}, {'pmid': '22345939', 'type': 'BACKGROUND', 'citation': 'Dave NM, Garasia M. A comparison of the effectiveness of predictors of caudal block in children-swoosh test, anal sphincter tone, and heart rate response. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):17-20. doi: 10.4103/0970-9185.92428.'}, {'pmid': '24174910', 'type': 'BACKGROUND', 'citation': 'Xu Z, Zhang J, Shen H, Zheng J. Assessment of pulse oximeter perfusion index in pediatric caudal block under basal ketamine anesthesia. ScientificWorldJournal. 2013 Sep 19;2013:183493. doi: 10.1155/2013/183493. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'A caudal epidural block is among the most widely administered techniques of regional anesthesia in pediatric patients. It helps in reducing the intraoperative dose of inhalational anesthetic agent used for maintenance of anesthesia and in addition provides an excellent postoperative analgesia without the side effects of intravenous opioid medication, like nausea and vomiting during emergence, cardiovascular, and respiratory depression. the aim of the study was to assess, perfusion index (PI) as an indicator for success of caudal block onset in pediatric patients scheduled for elective surgery of lower abdomen, pelvic region, genital region, or lower limbs.\n\nwith guidance of ultrasonography.', 'detailedDescription': 'It is performed by inserting a needle through the sacral hiatus to gain entrance into the sacral epidural space. Using conventional blind technique, the failure rate of caudal epidural block is high even in experienced hands. With the advent of ultrasound in guiding needle placement, the success rate of caudal epidural block has been markedly improved and could be effective in preventing complications during caudal epidural injection. After administration of a caudal block, reliable assessment of caudal block is very crucial to ascertain the success of block. The onset of caudal block is often assessed by cold stimuli and cutaneous temperature changes. Caudal block in pediatric patients is often performed under general anesthesia. Hence, testing the sensory levels by above techniques cannot be used. Also the change in the hemodynamic parameters are few other assessment methods. These methods are to be used 15-20 min after block administration, to confirm the efficacy of a caudal block. Perfusion index (PI), independent of parameters like heart rate, oxygen saturation of blood, or body temperature, measures the ratio of arterial blood flow (pulsatile flow) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and it is shown in percentage or absolute value . PI is considered as a sensitive marker to assess the efficacy of caudal block. It can detect the onset of caudal block, by increasing PI beyond the pre-induction values, which can be due to the sympathectomy induced after successful caudal administration,which increases the blood flow to the peripheral tissues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -ASA physical status I-II. -Both sexes -Age between 2 and 10 years -Patients scheduled for elective surgery of lower abdomen, pelvic region, genital region, or lower limbs.\n\nExclusion Criteria:\n\n* ASA physical status more than II.\n* Patients having any neurological disorders, bleeding disorder, bony deformity of vertebral column.\n\ninfection at the injection site, drug allergy, and undergoing anal surgery.'}, 'identificationModule': {'nctId': 'NCT06695520', 'briefTitle': 'Perfusion Index in Caudal Epidural Anasthesia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Is the Perfusion Index an Indicator for Success of Caudal Epidural Anasthesia in Pediatric Patients?', 'orgStudyIdInfo': {'id': 'Perfusion Index'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (A)', 'description': 'patients will receive General Anesthesia and Caudal Epidural Anesthesia', 'interventionNames': ['Procedure: Caudal epidural block']}, {'type': 'NO_INTERVENTION', 'label': 'GROUP (B)', 'description': 'patients will receive General Anesthesia only'}], 'interventions': [{'name': 'Caudal epidural block', 'type': 'PROCEDURE', 'description': 'Ultrasound Guidance: Using ultrasound improves the accuracy of the block by allowing real-time visualization of the anatomy and needle placement . injection: .5-1mg/kg of 25% bupivacaine according to the needed block level.', 'armGroupLabels': ['Group (A)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Monika Samir Melad Seha, resident doctor', 'role': 'CONTACT', 'email': 'Monica.16285820@med.aun.edu.eg', 'phone': '+2 01111782409'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at Anathesia , ICU & Pain Management', 'investigatorFullName': 'Monika Samir Melad', 'investigatorAffiliation': 'Assiut University'}}}}