Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 1:32 PM
Study NCT ID:
NCT05342259
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2022-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-01', 'studyFirstSubmitDate': '2022-03-08', 'studyFirstSubmitQcDate': '2022-04-16', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain scoring using the Wong Baker scale', 'timeFrame': '1st hour postoperatively', 'description': 'scale at 1st hour post operative, that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.'}, {'measure': 'pain scoring using the Wong Baker scale', 'timeFrame': '3rd hour postoperatively', 'description': 'scale at 3rd hour post operative, that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.'}, {'measure': 'pain scoring using the Wong Baker scale', 'timeFrame': '24th hour postoperatively', 'description': 'scale at 24th hour post operative, that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.'}], 'secondaryOutcomes': [{'measure': ': intra-operative heart rate (beats/ minuts).', 'timeFrame': 'scale at 1st hour post operative'}, {'measure': ': intra-operative heart rate (beats/ minuts).', 'timeFrame': 'scale at 3rd hour post operative'}, {'measure': ': intra-operative heart rate (beats/ minuts).', 'timeFrame': 'scale at 24th hour post operative'}, {'measure': 'intra-operative mean arterial blood pressure (mmhg)', 'timeFrame': 'intraoperatively'}, {'measure': 'complications', 'timeFrame': 'one day after operation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'in order to eliminate fear and anxiety. Regional techniques are more effective than systemic opioids, non steroidal anti-inflammatory drugs, and acetaminophen for postoperative analgesia in circumcision, The most preferred techniques are dorsal penile nerve block and caudal block.\n\nObjective: To investigate the effectiveness of post operative analgesia and complications among dorsal penile nerve block, caudal block and the combination of both.\n\nPatients and Methods: Our study was carried out to compare the effectiveness, duration of post-operative analgesia, and the complications among dorsal penile nerve block (DPNB), caudal nerve block (CNB) and the combination of both. This study will carrey out on 81 male patients, aged from 3-12 years old \\& undergoing circumcision. The patients were divided into 3 groups, each is composed of 27 patients; group 1 including DPNB patients, group 2 including CNB patients and group 3 for combined block. This study compared between the three groups regarding the intra-operative vital data (HR,BP), post-operative VAS scores and the complications (nausea, vomiting, urinary retention, itching, constipation \\& CNS depression).', 'detailedDescription': 'Cases were subdivided into three groups: Group 1: included dorsal penile block patients. Group 2: included caudal block patients. Group 3: included combined block patients.\n\nCircumcision was performed under general anesthesia and dorsal slit technique was used.\n\nStudy procedure:\n\nGeneral anesthesia was induced and maintained by inhalation of sevoflurane in oxygen mixed with air gas flow. A 22-G intravenous (i.v.) cannula was placed after induction. Spontaneous respiration was maintained via a selected laryngeal mask airway, and the inhaled sevoflurane was modified and maintained as 0.8 to 1.0MAC.\n\nBlock techniques:\n\nTechnique of the caudal block The patient was placed in lateral decubitus position for blind caudal epidural block. A line was drawn to connect the bilateral posterior superior iliac crests and used as one side of an equilateral triangle; then the location of the sacral hiatus was approximated by palpating the sacral cornua as 2 bony prominences, the sacral hiatus was identified as a dimple in between. A needle was inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone was contacted.\n\nA subjective feeling of loss of resistance suggests piercing the SCL but was associated with a miss rate up to 26% even in experienced hands. The "whoosh test," performed by auscultation at the thoracolumbar region with a stethoscope while injecting 2 mL of air, had a sensitivity of 80% and a specificity of 60% in adults. Palpating for subcutaneous bulging on rapid injection of 5 mL air or saline had a positive predictive value of 83% and a negative predictive value of 44%. The inaccuracy of using blind technique for caudal epidural injection in adults, even confirmed by various tests, is clearly evident.\n\nDrugs and doses used: 0.5 ml/kg of 0.25% Bupivacaine (diluted by saline solution 0.9).\n\nTechnique of Dorsal penile nerve block:\n\nUnder aseptic technique and under ultrasound guidance. A \'hockey-stick\' probe was used, covered by transparent sterile dressing. The probe was placed vertically over the pubic symphysis and the base of the penile shaft. With adjustment of the probe, a sagittal view of the penile shaft was produced. Scarpa\'s fascia was seen as a hyperechoic line superficial to the penile shaft. Under real-time guidance, the needle was inserted and advanced until its tip laid deep to Scarpa\'s fascia (i.e., within the subpubic space), where local anesthetic was deposited. The local anesthetic solution injected was 0.5% bupivacaine in a recommended volume. (2 ml up to 3 years and an additional 1 ml for each3 years up to maximum 6 ml). Combined block:\n\nThe caudal block was performed then the patient was placed in supine position and the DPNB was done .'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 3-12 years.\n* ASA I \\& II.\n\nExclusion Criteria:\n\n* Patient's refusal.\n* Contraindications to regional blocks as bleeding disorders and skin infections.\n* Drug hypersensitivity.\n* Failure of achieving block."}, 'identificationModule': {'nctId': 'NCT05342259', 'briefTitle': 'Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision', 'orgStudyIdInfo': {'id': 'FMASU MS 573/ 2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dorsal penile block patients', 'interventionNames': ['Procedure: Dorsal penile nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'caudal block patients', 'interventionNames': ['Procedure: Caudal nerve block /neuroaxial']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'combined block patients', 'interventionNames': ['Procedure: Combined caudal and dorsal penile nerve block']}], 'interventions': [{'name': 'Caudal nerve block /neuroaxial', 'type': 'PROCEDURE', 'description': 'Technique of the caudal block The patient was placed in lateral decubitus position for blind caudal epidural block. A line was drawn to connect the bilateral posterior superior iliac crests and used as one side of an equilateral triangle; then the location of the sacral hiatus was approximated by palpating the sacral cornua as 2 bony prominences, the sacral hiatus was identified as a dimple in between. A needle was inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone was contacted.\n\nA subjective feeling of loss of resistance suggests piercing the sacral ligament.The "whoosh test," performed by auscultation at the thoracolumbar region with a stethoscope while injecting 2 mL of air, Palpating for subcutaneous bulging on rapid injection of 5 mL air or saline had a positive predictive value of 83% and a negative predictive value of 44%.', 'armGroupLabels': ['caudal block patients']}, {'name': 'Dorsal penile nerve block', 'type': 'PROCEDURE', 'description': "Technique of Dorsal penile nerve block:\n\nUnder aseptic technique and under ultrasound guidance. A 'hockey-stick' probe was used, covered by transparent sterile dressing. The probe was placed vertically over the pubic symphysis and the base of the penile shaft. With adjustment of the probe, a sagittal view of the penile shaft was produced. Scarpa's fascia was seen as a hyperechoic line superficial to the penile shaft. Under real-time guidance, the needle was inserted and advanced until its tip laid deep to Scarpa's fascia (i.e., within the subpubic space), where local anesthetic was deposited. The local anesthetic solution injected was 0.5% bupivacaine in a recommended volume. (2 ml up to 3 years and an additional 1 ml for each3 years up to maximum 6 ml).", 'armGroupLabels': ['dorsal penile block patients']}, {'name': 'Combined caudal and dorsal penile nerve block', 'type': 'PROCEDURE', 'description': 'Combined techniques of caudal and dorsal penile nerve block', 'armGroupLabels': ['combined block patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia', 'investigatorFullName': 'RAMY AHMED', 'investigatorAffiliation': 'Ain Shams University'}}}}