Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-15 @ 6:45 PM
Study NCT ID:
NCT05922605
Status:
UNKNOWN
Last Update Posted:
2023-10-30
First Post:
2023-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias
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': 'C000629870', 'term': 'Esketamine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The Patients allocated to study groups using computer generates random list \\& group assignment is sealed in sequentially numbered opaque envelopes that open after induction of anesthesia.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of caudal analgesia', 'timeFrame': '48 hours after the caudal injection', 'description': 'Duration of analgesia is defined as the time from caudal injection to the first need for systemic analgesia.'}], 'secondaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': '48 hours after caudal block', 'description': 'The Face, Legs, Activity, Cry, and Consolability (FLACC) scale at 1 hour (h), 3h,6h,12h,24h,48h or the time when children complain of pain after surgery. A score of more than 3 points is taken as an indication of inadequate analgesia and morphine 15ug/kg was administered .'}, {'measure': 'FLACC score', 'timeFrame': '48 hours after the caudal block', 'description': 'The Face, Legs, Activity, Cry, and Consolability (FLACC) scale'}, {'measure': 'complication', 'timeFrame': '48 hours after the caudal block', 'description': 'the incidence of residual motor block, urinary retention, paraesthesia; the incidence of respiratory depression ,vomiting ,nystagmus ,pruritus，odd behavior;.the sedation scores etc.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Analgesia', 'S-ketamine', 'Pediatrics', 'Caudal Block', 'Hypospadias']}, 'referencesModule': {'references': [{'pmid': '15200652', 'type': 'BACKGROUND', 'citation': 'Gunes Y, Secen M, Ozcengiz D, Gunduz M, Balcioglu O, Isik G. Comparison of caudal ropivacaine, ropivacaine plus ketamine and ropivacaine plus tramadol administration for postoperative analgesia in children. Paediatr Anaesth. 2004 Jul;14(7):557-63. doi: 10.1111/j.1460-9592.2004.01220.x.'}, {'pmid': '11696143', 'type': 'BACKGROUND', 'citation': 'De Negri P, Ivani G, Visconti C, De Vivo P. How to prolong postoperative analgesia after caudal anaesthesia with ropivacaine in children: S-ketamine versus clonidine. Paediatr Anaesth. 2001 Nov;11(6):679-83. doi: 10.1046/j.1460-9592.2001.00742.x.'}, {'pmid': '12641687', 'type': 'BACKGROUND', 'citation': 'Weber F, Wulf H. Caudal bupivacaine and s(+)-ketamine for postoperative analgesia in children. Paediatr Anaesth. 2003 Mar;13(3):244-8. doi: 10.1046/j.1460-9592.2003.01018.x.'}, {'pmid': '14742331', 'type': 'BACKGROUND', 'citation': 'Martindale SJ, Dix P, Stoddart PA. Double-blind randomized controlled trial of caudal versus intravenous S(+)-ketamine for supplementation of caudal analgesia in children. Br J Anaesth. 2004 Mar;92(3):344-7. doi: 10.1093/bja/aeh076. Epub 2004 Jan 22.'}, {'pmid': '11020749', 'type': 'BACKGROUND', 'citation': 'Koinig H, Marhofer P, Krenn CG, Klimscha W, Wildling E, Erlacher W, Nikolic A, Turnheim K, Semsroth M. Analgesic effects of caudal and intramuscular S(+)-ketamine in children. Anesthesiology. 2000 Oct;93(4):976-80. doi: 10.1097/00000542-200010000-00017.'}, {'pmid': '21642642', 'type': 'BACKGROUND', 'citation': 'Brenner L, Marhofer P, Kettner SC, Willschke H, Machata AM, Al-Zoraigi U, Lundblad M, Lonnqvist PA. Ultrasound assessment of cranial spread during caudal blockade in children: the effect of different volumes of local anaesthetics. Br J Anaesth. 2011 Aug;107(2):229-35. doi: 10.1093/bja/aer128. Epub 2011 Jun 3.'}, {'pmid': '30243061', 'type': 'BACKGROUND', 'citation': 'Narasimhan P, Kashyap L, Mohan VK, Arora MK, Shende D, Srinivas M, Kashyap S, Nath S, Khanna P. Comparison of caudal epidural block with paravertebral block for renal surgeries in pediatric patients: A prospective randomised, blinded clinical trial. J Clin Anesth. 2019 Feb;52:105-110. doi: 10.1016/j.jclinane.2018.09.007. Epub 2018 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'Caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. However, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious.\n\nKetamine as an additive to caudal administration had been shown to prolong the duration of postoperative analgesia, while the analgesic effectiveness of S-ketamine, the S(+)-enantiomer of ketamine with less possibility to induce psychomotor disturbances, is not clear. In this prospective randomized double-blind clinical trial , the investigators aimed to study the effect of S-ketamine as additive on the duration of caudal analgesia.', 'detailedDescription': 'Forty-four children scheduled for hypospadias randomize into 2 groups. Group E (n=22) (0.2% ropivacaine 0.7 ml／kg and S-ketamine 0.5 mg/kg), group C(n=22)( 0.2%ropivacaine 0.7ml／kg and equivalent saline) intraoperative and postoperative hemodynamics will be recorded. Postoperative pain is assessed using an established 6-item FLACC score at 1h,3h,6h,12h,24h,48h, or the time when children complain of pain after surgery. A score of more15μg/kg is administered.Investigators propose to compare the duration of caudal analgesia provided by plain ropivacaine and by a mixture of ropivacaine and S-ketamine.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed parent consent, ASA I or II children, between 3months and 18 years of age,and weighing \\<28kg, scheduled for elective hypospadias surgery with general anesthesia will be recruited.\n\nExclusion Criteria:\n\n* Patients who have congenital abnormalities of lower spine and meninges.\n* Patients with hypersensitivity to any local anesthetics\n* Children with coagulation disorders\n* Presence of Infections at puncture sites\n* Preexisting neurological disease\n* Refusal to consent by parent/guardian'}, 'identificationModule': {'nctId': 'NCT05922605', 'briefTitle': 'Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias', 'orgStudyIdInfo': {'id': 'Caudal S-ketamine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group E', 'description': 'the children are given a mixture of 0.2%ropivacaine 0.7 ml／kg and preservative-free S-ketamine 0.5 mg/kg for caudal analgesia.', 'interventionNames': ['Drug: S-ketamine & Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'The children are given 0.2%ropivacaine 0.7 ml／kg and saline of equal volume caudally.', 'interventionNames': ['Drug: Ropivacaine']}], 'interventions': [{'name': 'S-ketamine & Ropivacaine', 'type': 'DRUG', 'description': 'The experiment group (Group E) will receive a mixture of ropivacaine 0.2% 0.7 ml／kg and preservative-free S-ketamine 0.5 mg/kg caudally for postoperative analgesia.', 'armGroupLabels': ['Group E']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'The experiment group (Group C) will receive ropivacaine 0.2% 0.7 ml／kg plain and equial volume saline caudally for postoperative analgesia.', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xia Feng, MD', 'role': 'CONTACT', 'email': 'fengxia@mail.sysu.edu.cn', 'phone': '8613688877856'}], 'facility': 'First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'tao Zhang, MD', 'role': 'CONTACT', 'email': 'zhtao98@aliyun.com', 'phone': '8613580482938'}, {'name': 'weiyi Xu, B.M', 'role': 'CONTACT', 'email': 'xuweiyi75@foxmail.com', 'phone': '8619875691896'}], 'overallOfficials': [{'name': 'Tao Zhang, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tao Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tao Zhang', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}