Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04475458
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2020-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-05', 'studyFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to discharge', 'timeFrame': '1 hour after end of surgery', 'description': 'The time to discharge from the operating room to the post-anesthesia care unit is measured and compared between the two groups.'}], 'secondaryOutcomes': [{'measure': 'Number of patients needed ventilation', 'timeFrame': '1 hour after beginning of surgery', 'description': 'Patients who received general anesthesia where all ventilated mechanically. In the ultrasound group, patients maintained spontaneous breathing and were noted the ones who needed ventilation.'}, {'measure': 'Opioid sparing', 'timeFrame': '1 hour after beginning of surgery', 'description': 'The dosage of opioids were measured and compared between the two groups.'}, {'measure': 'Postoperative pain', 'timeFrame': 'Immediately after surgery, 4 and 72 hours after surgery', 'description': 'Pain levels were compared between the two groups with the Faces, Legs, Activity, Cry and Consolability (FLACC) scale for children \\< 3 years (a score between 0 and 3 corresponds to a slight pain, in the range 4-7 to moderate pain and score\\> 7 to a severe pain), faces pain scale for children between 3 e 8 years (the scale shows a series of faces ranging from a happy face or no hurt at score 0, to a crying face at score 10, which represents "hurts like the worst pain imaginable", the patient chooses the face that best describes their level of pain) and the numerical rate scale (NRS) for children \\> 8 years-old (patients are asked to circle the number between 0 and 10 that fits best to their pain intensity, zero represents \'no pain at all\' whereas the upper limit represents \'the worst pain ever possible\'). Analgesics and nonsteroidal anti-inflammatory drugs were registered in the two groups.'}, {'measure': 'Complications', 'timeFrame': 'Immediately after surgery, 4 and 72 hours after surgery', 'description': 'Postoperative complications were analyzed and compared between the two groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dorsal nerve penis block', 'sedation', 'spontaneous breathing', 'circumcision', 'pediatric surgery', 'ultrasound guided'], 'conditions': ['Child, Only']}, 'referencesModule': {'references': [{'pmid': '18843636', 'type': 'BACKGROUND', 'citation': 'Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.'}, {'pmid': '29939703', 'type': 'BACKGROUND', 'citation': 'Suleman MI, Akbar Ali AN, Kanarek V, Li M, Patel A. Ultrasound Guided In-Plane Penile Nerve Block for Circumcision: A New, Modified Technique Suggests Lower Anesthetic Volume and Narcotic Use. Middle East J Anaesthesiol. 2016 Oct;23(6):647-53.'}, {'pmid': '17444318', 'type': 'BACKGROUND', 'citation': 'Sandeman DJ, Dilley AV. Ultrasound guided dorsal penile nerve block in children. Anaesth Intensive Care. 2007 Apr;35(2):266-9. doi: 10.1177/0310057X0703500217.'}, {'pmid': '22023417', 'type': 'BACKGROUND', 'citation': "O'Sullivan MJ, Mislovic B, Alexander E. Dorsal penile nerve block for male pediatric circumcision--randomized comparison of ultrasound-guided vs anatomical landmark technique. Paediatr Anaesth. 2011 Dec;21(12):1214-8. doi: 10.1111/j.1460-9592.2011.03722.x."}, {'pmid': '38116040', 'type': 'DERIVED', 'citation': 'Dottore B, Meroi F, Tomasino S, Orso D, Comuzzi M, Vernaccini N, Vetrugno L, Intini S, Bove T. Pediatric ultrasound-guided dorsal penile nerve block and sedation in spontaneous breathing: a prospective observational study. Front Med (Lausanne). 2023 Dec 4;10:1268594. doi: 10.3389/fmed.2023.1268594. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'One of the most frequent surgical procedures in the pediatric population is circumcision, following which postoperative pain could be stressful. Usually, the most common approach is combining regional anesthesia techniques such as landmark dorsal penile nerve block (DPNB) with general anesthesia (GA). The hypothesis of this study investigates ultrasound-guided DPNB plus sedation in spontaneous breathing.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients' anthropometric data were collected. Data related to the anesthetic technique, pharmacological therapy, vital parameters were registered as well as the time to discharge from the operatory room to the post-anesthesia care unit.\n\nOpioid consumption and nonsteroidal anti-inflammatory drugs during and after surgery were noted. Pain and complications immediately after surgery, at 4 and 72 hours after surgery were registered.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* candidates to circumcision\n* age between 6 months and 17 years\n* American Society of Anesthesiologists (ASA) physical status \\< 3\n* written consent of the parents\n\nExclusion Criteria:\n\n* allergies to local anesthetics\n* younger than 6 months and older than 17 years\n* ASA physical status =/\\> 3\n* no written consent of the parents'}, 'identificationModule': {'nctId': 'NCT04475458', 'briefTitle': 'Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Sanitaria-Universitaria Integrata di Udine'}, 'officialTitle': 'Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing: An Observational Study', 'orgStudyIdInfo': {'id': 'Ultrasound guided DPNB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LANDMARK', 'description': 'The children who underwent circumcision received general anesthesia plus dorsal penis nerve block performed by the surgeon with a landmark technique.'}, {'label': 'ULTRASOUND', 'description': 'The children who underwent circumcision received sedation (in spontaneous breathing) plus ultrasound-guided dorsal penis nerve block.', 'interventionNames': ['Procedure: Ultrasound-guided dorsal penile nerve block']}], 'interventions': [{'name': 'Ultrasound-guided dorsal penile nerve block', 'type': 'PROCEDURE', 'description': "This block is performed by the anesthesiologist, after sedation. With an in-plane approach, the tissues around the dorsal penis nerves are visualized. The needle has to pass through Buck's fascia and there the local anesthetic is released.", 'armGroupLabels': ['ULTRASOUND']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Sanitaria-Universitaria Integrata di Udine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Luigi Vetrugno', 'investigatorAffiliation': 'Azienda Sanitaria-Universitaria Integrata di Udine'}}}}