Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2026-01-02 @ 3:01 AM
Study NCT ID:
NCT02848157
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2016-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dexmedetomidine as Adjunct to Pudendal Block for Pediatric Penile Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007021', 'term': 'Hypospadias'}], 'ancestors': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-15', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-27', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1st analgesic request time', 'timeFrame': 'until 24 hours after surgery', 'description': 'time to first rescue medication, assessed up to 24 h (time frame: from the administration of the pudendal block to the first registration of a FLACC≥4) (FLACC: face, legs, activity, cry, consolability)'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain evaluated by the FLACC scale', 'timeFrame': 'The time of arrival in the recovery room, 10, 20, 30 min after arrival of the recovery room, and 4, 8, 12, 24 h after the surgery.', 'description': 'Postoperative pain is evaluated by the FLACC scale'}, {'measure': 'Emergence delirium evaluated by the pediatric anesthesia emergence delirium scale', 'timeFrame': 'The time of arrival in the recovery room, 10, 20, 30 min after arrival of the recovery room, and through the time of discharge from the PACU, an average of 30 minutes', 'description': 'emergence delirium is evaluated by the pediatric anesthesia emergence delirium scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'pudendal block', 'hypospadias'], 'conditions': ['Elective Penile Surgeries', 'Hypospadias', 'Urethral Fistula or Stricture After Hypospadias Repair', 'Penile Curvature']}, 'descriptionModule': {'briefSummary': 'Caudal block is often performed to relieve postoperative pain in pediatric urological surgery. Recently, pudendal block is also used in penile surgery and it has advantage because of less side effects such as transient weakness of low extremities, but limited to use in penile surgery. Local anesthesia is a single shot injection, so additional analgesic drugs is required when the effect of local anesthetics are disappeared. Dexmedetomidine, an alpha adrenergic agonist, is commonly used in pediatric sedation. It has analgesic effect and potentiates the effect of local anesthetics. There are many studies about the potentiation of the effect of local anesthetics when added to dexmedetomidine in adults, it has been limited in pediatrics. Recent study said that local anesthetics with dexmedetomidine had prolonged duration of analgesia in caudal block, also in ilioinguinal block. Thus it is expected to have a prolonged effect when investigators use dexmedetomidine in pediatrics as well as adults.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients aged between 6 months and 6 years in elective penile surgeries (hypospadias, urethral fistula or stricture after hypospadias repair, penile curvature)\n2. American Society of Anesthesiologists (ASA) class I, II\n\nExclusion Criteria:\n\n1. Coagulopathy\n2. allergy to local anesthetics\n3. meatal island onlay proximal transverse island flap (MIOPTI) (more than 4 h for the surgery)\n4. illiteracy, foreigner'}, 'identificationModule': {'nctId': 'NCT02848157', 'briefTitle': 'Effects of Dexmedetomidine as Adjunct to Pudendal Block for Pediatric Penile Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2016-0379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DR', 'description': 'dexmedetomidine 0.3mcg/kg and 0.25% ropivacaine 0.3ml/kg', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PR', 'description': '0.25% ropivacaine 0.3ml/kg', 'interventionNames': ['Drug: plain ropivacaine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': "Patients are put in lithotomy position. Two separate injection points are marked at 3 and 9 o'clock, about 2 to 2.5 cm from the center of anus. After aseptic preparation, a nerve stimulator needle advanced 1.5 to 3.5 cm perpendicular to the skin, and stimulation current is 2.5 to 5 mA. The unilateral contraction of anal sphincter means the inferior anal nerve stimulation. After reducing the current to 0.5 mA, the needle is then moved deeper until an up-and-down penile movement is observed. This is stimulation of the perineal branch of the pudendal nerve. Prepared drug (0.25% ropivacaine and 0.3 mcg/kg dexmedetomidine in the experimental group, and equivalent doses of ropivacaine and normal saline in the control group) is injected in half and half bilaterally.", 'armGroupLabels': ['DR']}, {'name': 'plain ropivacaine', 'type': 'DRUG', 'description': 'ropivacaine and normal saline equivalent doses of dexmedetomidine', 'armGroupLabels': ['PR']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'armGroupLabels': ['DR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}