Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-22 @ 12:13 PM
Study NCT ID:
NCT05284734
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Postoperative pain', 'timeFrame': 'Up to 24 hours', 'description': 'It was assessed seven times after the operation with Face, Legs, Activity, Cry, Consolability (FLACC) scale. The lowest scale score is 0 points and the highest 10 points.\n\nFollowing transfer from the recovery unit to the ward, the 1st, 2nd, 4th, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse.'}], 'secondaryOutcomes': [{'measure': 'Time of Postoperative analgesic requirement', 'timeFrame': 'Up to 24 hours', 'description': 'It was assessed seven times after the operation with Face, Legs, Activity, Cry, Consolability (FLACC) scale. The lowest scale score is 0 points and the highest 10 points. Significant pain behavior for the scale has been identified as 4 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse. Paracetamol was administered IV at a dose of 10 mg/kg if the scale score was 4 or higher.'}, {'measure': 'Rate of Postoperative complications', 'timeFrame': 'Up to 24 hours', 'description': 'Urinary retention, hematoma, ecchymosis, motor block were postoperative complications. They were assessed by an anesthesiologist.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'Pain', 'Caudal block', 'Erector spinae block'], 'conditions': ['Circumcision', 'Lower Abdominal Surgery']}, 'referencesModule': {'references': [{'pmid': '30868029', 'type': 'BACKGROUND', 'citation': 'Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815.'}, {'pmid': '32791500', 'type': 'BACKGROUND', 'citation': 'Ozen V, Yigit D. A Comparison of the Postoperative Analgesic Effectiveness of Ultrasound-Guided Dorsal Penile Nerve Block and Ultrasound-Guided Pudendal Nerve Block in Circumcision. Urol Int. 2020;104(11-12):871-877. doi: 10.1159/000509173. Epub 2020 Aug 13.'}, {'pmid': '32507565', 'type': 'BACKGROUND', 'citation': 'Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.'}, {'pmid': '40228275', 'type': 'DERIVED', 'citation': 'Ozen V, Turan EI, Kirdan T, Ayas TA, Erten E, Karacalar S. Erector spinae plane block as an alternative to caudal block in concurrent pediatric urologic and inguinal surgery: A double-blinded randomized controlled trial. Medicine (Baltimore). 2025 Apr 11;104(15):e42109. doi: 10.1097/MD.0000000000042109.'}]}, 'descriptionModule': {'briefSummary': 'Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients.', 'detailedDescription': 'Circumcision and any lower abdominal surgery in the pediatric population result in a very painful postoperative period, even when each procedure is evaluated separately. Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients. As far as we know, there is no previous study in the literature comparing CB and ESP block in pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-7 years of age\n* ASA (American Society of Anesthesiologists) I-II group\n* Scheduled for circumcision and unilateral lower abdominal surgery at the same session\n* Able to communicate in Turkish\n* Willing to participate to the study (parents and children)\n\nExclusion Criteria:\n\n* Less than 1 or more than 7 years of age\n* A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital lumbar anomaly, liver and/or kidney disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination\n* Unwilling to to participate to the study ((parents or children)'}, 'identificationModule': {'nctId': 'NCT05284734', 'briefTitle': 'Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia in Circumcision and Lower Abdominal Surgery in Pediatric Patients: A Double-blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2021.42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caudal block group', 'description': 'A 22 gauge 50 mm echogenic block needle placed through the sacrococcygeal membrane into the sacral canal in the longitudinal position, using the in-plane technique Negative aspiration was then performed 0.125% bupivacaine at a dose of 1 ml/kg was administered', 'interventionNames': ['Procedure: Regional anesthesia intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Erector spinae block group', 'description': 'The erector spinae muscle and the transverse process were identified, and a 22 G, 80 mm echogenic block needle was advanced towards the transverse process until contact. Following hydrodissection, 1 ml/kg of 0.125% bupivacaine was injected deep into the erector spinae muscle', 'interventionNames': ['Procedure: Regional anesthesia intervention']}], 'interventions': [{'name': 'Regional anesthesia intervention', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided caudal and erector spinae blocks were administered', 'armGroupLabels': ['Caudal block group', 'Erector spinae block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34384', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Prof. Dr. Cemil Tascioglu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Volkan Özen, Asso.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Volkan Ozen', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}