Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT04367818
Status:
UNKNOWN
Last Update Posted:
2021-08-23
First Post:
2020-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Could Peri-anal Block be Effective as Caudal Block in Trans-anal Pull-through Surgery ??.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain relieve', 'timeFrame': '24 hours', 'description': 'Assessment of postoperative pain using FLACC scale and the time to first analgesia request.'}], 'secondaryOutcomes': [{'measure': "Ramsay's sedation scale", 'timeFrame': '24 hours', 'description': "Assessment of postoperative sedation using (Ramsay's sedation scale)."}, {'measure': 'Postoperative motor power', 'timeFrame': '24 hours', 'description': 'Assessment of postoperative motor power.'}, {'measure': 'Postoperative Complication', 'timeFrame': '24 hours', 'description': 'Assessment of postoperative Complication (nausea, vomiting, bradycardia with heart rate\\< 80 or hypotension as systolic blood pressure\\< {70+age in year \\*2}).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'referencesModule': {'references': [{'pmid': '12644422', 'type': 'BACKGROUND', 'citation': 'de Beer DA, Thomas ML. Caudal additives in children--solutions or problems? Br J Anaesth. 2003 Apr;90(4):487-98. doi: 10.1093/bja/aeg064. No abstract available.'}, {'pmid': '12739325', 'type': 'BACKGROUND', 'citation': 'Gopal DV. Diseases of the rectum and anus: a clinical approach to common disorders. Clin Cornerstone. 2002;4(4):34-48. doi: 10.1016/s1098-3597(02)90004-9.'}, {'pmid': '10859082', 'type': 'BACKGROUND', 'citation': 'Gabrielli F, Cioffi U, Chiarelli M, Guttadauro A, De Simone M. Hemorrhoidectomy with posterior perineal block: experience with 400 cases. Dis Colon Rectum. 2000 Jun;43(6):809-12. doi: 10.1007/BF02238019.'}, {'pmid': '10696885', 'type': 'BACKGROUND', 'citation': 'Luck AJ, Hewett PJ. Ischiorectal fossa block decreases posthemorrhoidectomy pain: randomized, prospective, double-blind clinical trial. Dis Colon Rectum. 2000 Feb;43(2):142-5. doi: 10.1007/BF02236970.'}, {'pmid': '15057585', 'type': 'BACKGROUND', 'citation': 'Nystrom PO, Derwinger K, Gerjy R. Local perianal block for anal surgery. Tech Coloproctol. 2004 Mar;8(1):23-6. doi: 10.1007/s10151-004-0046-8.'}, {'pmid': '25379541', 'type': 'BACKGROUND', 'citation': 'Kaban OG, Yazicioglu D, Akkaya T, Sayin MM, Seker D, Gumus H. Spinal anaesthesia with hyperbaric prilocaine in day-case perianal surgery: randomised controlled trial. ScientificWorldJournal. 2014;2014:608372. doi: 10.1155/2014/608372. Epub 2014 Oct 14.'}, {'pmid': '24474180', 'type': 'BACKGROUND', 'citation': 'Zhang Y, Bao Y, Li L, Shi D. The effect of different doses of chloroprocaine on saddle anesthesia in perianal surgery. Acta Cir Bras. 2014 Jan;29(1):66-70. doi: 10.1590/S0102-86502014000100010.'}, {'pmid': '19133521', 'type': 'BACKGROUND', 'citation': 'Anannamcharoen S, Cheeranont P, Boonya-usadon C. Local perianal nerve block versus spinal block for closed hemorrhoidectomy: a ramdomized controlled trial. J Med Assoc Thai. 2008 Dec;91(12):1862-6.'}]}, 'descriptionModule': {'briefSummary': 'IN pediatric patient population pain is considered one of the most misunderstood; under diagnosed and under treated medical problems. If left uncontrolled, pain may have a diverse effect on all aspects of life as it is only a sensory perception but also has emotional, cognitive and behavioral components.', 'detailedDescription': "Caudal anesthesia is one of the most commonly used regional anesthetic and analgesic technique in pediatric patient as it is an easy safe and reliable method that can be performed for both intraoperative and postoperative analgesia in patient undergoing lower abdominal and lower limb surgery. It can be used for upper abdominal surgery by increasing the volume of local anesthetic injected or through advancing a catheter.\n\nCaudal anesthesia is a common practice given along with general anesthesia to decrease intraoperative inhalational anesthesia requirements, postoperative pain and emergence agitation.\n\nSo many patients are complaining from ano-rectal pathologies, these diseases are common in both sexes and all age groups. The spectrum of anorectal disorders ranges from benign and irritating (pruritus- ani) to potentially life-threatening (anorectal cancer) and the surgical intervention is performed mostly under general or regional anesthesia.\n\nWhile general and regional anesthetics provide reliable anesthesia, they are often associated with nausea,vomiting, urinary retention and motor blockade of lower limbs. Moreover, repeated spinal or epidural punctures performed by inexperienced anesthesiologists often cause delays in the tight schedule of operations.\n\nSeveral reports have described various forms of local anesthetic infiltration for ano- rectal surgery , hemorrhoidectomy,anal fistula or fissure surgeries or lateral sphincterotomy. Local peri-anal infiltration is a simple procedure that can be easily learned and performed by surgeon and this method allows the operation to begin almost immediately.\n\nThere are different types of local anesthesia like infiltration, nerve block, ring block field block. Considering anorectal surgeries, nerve bock mainly pudendal nerve along with infiltration anesthesia is used worldwide. Perianal block by local anesthetic infiltration is safe simple and effective for various anal operations with very high degree of acceptance and satisfaction among patients .it had been found to be associated with low pain score and postoperative complications and faster return to daily social activity.\n\nAlthough there are studies on the use of caudal block and local infiltration of anesthetic agent for the surgical resolution of anorectal pathologies, there is no established protocol for comparing efficacy, postoperative pain, and satisfaction among pediatrics patient undergoing trans-anal pull through in congenital megacolon (Hirschsprung's disease)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes.\n* Patients with age range 3 to 10 years old.\n* Patients with ASA 1 , 2 classification.\n\nExclusion Criteria:\n\n* Patient or parents refusal.\n* Allergy to the study drugs.\n* Suspect coagulopathy.\n* Local infection at site of intervention.\n* History of developmental delay.\n* Neuromuscular disorders.\n* Skeletal deformity.'}, 'identificationModule': {'nctId': 'NCT04367818', 'briefTitle': 'Could Peri-anal Block be Effective as Caudal Block in Trans-anal Pull-through Surgery ??.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Could Peri-anal Block be Effective as Caudal Block in Trans-anal Pull-through Surgery for Children With Hirschsprung Disease??. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'CPABBEACB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Peri-anal local anaesthetic infiltration', 'description': 'Patients in this group will receive the prepared anesthetic mixture (bupivacaine 0.25% in dose of 1ml\\\\kg plus dexametomidine 2ug\\\\kg diluted in 0.5ml of normal saline) in a syringe will be connected to 22\\_ gauge short, beveled needle. The technique of the block will be done guided by Nystrom et al.', 'interventionNames': ['Procedure: Peri-anal local anaesthetic infiltration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'caudal anaesthesia', 'description': 'Patients in this group will receive caudal block using 22\\_gauge short, beveled cannula or needle, The prepared anesthetic mixture (bupivacaine 0.25% in dose of 1ml\\\\kg plus dexametomidine 2ug\\\\kg diluted in 0.5ml of normal saline).', 'interventionNames': ['Procedure: Caudal anaesthesia']}], 'interventions': [{'name': 'Peri-anal local anaesthetic infiltration', 'type': 'PROCEDURE', 'description': 'postoperative pain relieve, among pediatrics patient', 'armGroupLabels': ['Peri-anal local anaesthetic infiltration']}, {'name': 'Caudal anaesthesia', 'type': 'PROCEDURE', 'description': 'Regional anaesthesia for postoperative pain relieve, among pediatrics patient', 'armGroupLabels': ['caudal anaesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Salah Rashed, Resident', 'role': 'CONTACT', 'email': 'mohamed011360@med.aun.edu.eg', 'phone': '01002360078'}, {'name': 'Esam Eldin Abdalla, professor', 'role': 'CONTACT', 'email': 'esamel_deen@yahoo.com', 'phone': '01009633737'}], 'facility': 'Mohamed Salah Rashed', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Esam Abdalla, Professor', 'role': 'CONTACT', 'email': 'esamel_deen@yahoo.com', 'phone': '01009633737'}, {'name': 'Fatma Nabil, Professor', 'role': 'CONTACT', 'phone': '01003633992'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Salah Rashed Abd Elraheem', 'investigatorAffiliation': 'Assiut University'}}}}