Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT05448495
Status:
UNKNOWN
Last Update Posted:
2022-07-15
First Post:
2022-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-13', 'studyFirstSubmitDate': '2022-07-02', 'studyFirstSubmitQcDate': '2022-07-02', 'lastUpdatePostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time to first call rescue analgesia', 'timeFrame': 'From end of surgery till 24 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous nephrolithotomy', 'Erector spinae plane block', 'Transversus abdominis plane block'], 'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'To compare the analgesic efficacy of posterior TAP block versus ESPB after PCNL surgery. The hypothesis is that posterior TAP block, as a part of multimodal analgesia, will reduce pain and opioid consumption like ESPB', 'detailedDescription': 'Percutaneous nephrolithotomy (PCNL) is currently the gold standard for treatment of patients with large and complex renal calculi because it is less invasive than open surgery. The sources of acute pain after PCNL are visceral pain originating from kidneys and ureters, and somatic pain from the site incision. PCNL is usually done in 10th to 11th intercostal space or in the subcostal area. Complete blockade of unilateral spinal nerves from T10 to L2 can provide sufficient analgesia during PCNL. This can be achieved by several regional techniques such as thoracic paravertebral block, transversus abdominis plane (TAP) block, erector spinae plane block (ESPB).\n\nESPB is an interfascial block which can provide wide sensory blockade from T2-4 to L1-2 that was first described in 2016. ESPB can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle with nearly one dermatome for each 3.4 ml of the injected volume. This allows ESPB to provide both visceral and somatic analgesia. TAP block is a regional injection of a local anesthetic agent between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1). Various technical modifications in TAP block have been described including lateral, posterior, subcostal, and continuous catheter techniques. The posterior approach should be the preferred technique in clinical practice as it provides longer somatic and visceral analgesia that are not offered with the lateral approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for PCNL under general anesthesia\n* ASA status I-II\n\nExclusion Criteria:\n\n1. Contraindications to regional block (coagulopathy, infection at the needle insertion site or known allergy to amide local anesthetics)\n2. Patient who has difficulty understanding the study protocol or patient refusal.\n3. Chronic respiratory disease patients.\n4. Diabetic patients.\n5. Body mass index (BMI) \\> 30 Kg/m2\n6. Routine corticosteroids, pain medication, or anticonvulsant.\n7. Psychiatric diseases.'}, 'identificationModule': {'nctId': 'NCT05448495', 'briefTitle': 'Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy. A Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Posterior TAPB versus ERSPB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Posterior TAP block', 'interventionNames': ['Other: Posterior TAP block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ESPB', 'interventionNames': ['Other: ESPB']}], 'interventions': [{'name': 'Posterior TAP block', 'type': 'OTHER', 'otherNames': ['Posterior transversus abdominis plane block'], 'description': 'Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine \\[0.5 mcg\\\\kg\\] + 2ml dexamethasone \\[0.1mg\\\\kg)\\] will be injected at the plane between internal oblique and transversus abdominis near the aponeurosis at the posterior axillary line.', 'armGroupLabels': ['Posterior TAP block']}, {'name': 'ESPB', 'type': 'OTHER', 'otherNames': ['Erector spinae plane block'], 'description': 'Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine \\[0.5 mcg\\\\kg\\] + 2ml dexamethasone \\[0.1mg\\\\kg)\\] will be injected at T9 erector spinae plane', 'armGroupLabels': ['ESPB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Fatma Nabil, M.D.', 'role': 'CONTACT', 'email': 'fatmanabil2012@aun.edu.eg', 'phone': '+201003633992'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Fatma Nabil, M.D.', 'role': 'CONTACT', 'email': 'fatmanabil2012@aun.edu.eg', 'phone': '+201003633992'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'FATMA NABIL AHMED MOHAMED', 'investigatorAffiliation': 'Assiut University'}}}}