Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-27 @ 2:12 AM
Study NCT ID:
NCT06336161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Post-operative Pain', 'timeFrame': 'the first 24 hours postoperatively', 'description': 'Assessment of Pain after operations will be evaluated using the VAS consisting of a horizontal or vertical line, 10 centimeters long (100 mm) anchored at the extremes by two verbal descriptors referring to the pain status'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '37737097', 'type': 'RESULT', 'citation': 'Patel Y, Ramachandran K, Shetty AP, Chelliah S, Subramanian B, Kanna RM, Shanmuganathan R. Comparison Between Relative Efficacy of Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Lumbar Fusion Surgery- A Prospective Randomized Controlled Study. Global Spine J. 2025 Mar;15(2):639-647. doi: 10.1177/21925682231203653. Epub 2023 Sep 22.'}, {'pmid': '32864257', 'type': 'RESULT', 'citation': 'Shah M, Halalmeh DR, Sandio A, Tubbs RS, Moisi MD. Anatomical Variations That Can Lead to Spine Surgery at the Wrong Level: Part III Lumbosacral Spine. Cureus. 2020 Jul 28;12(7):e9433. doi: 10.7759/cureus.9433.'}], 'seeAlsoLinks': [{'url': 'https://link.springer.com/chapter/10.1007/978-3-030-87266-3_3', 'label': 'Acute Postoperative Pain: Patient-Controlled Analgesia'}, {'url': 'https://ejrnm.springeropen.com/articles/10.1186/s43055-020-00388-8', 'label': 'Caudal epidural steroid injection ultrasound-guided versus fluoroscopy-guided in treatment of refractory lumbar disc prolapse with radiculopathy'}]}, 'descriptionModule': {'briefSummary': "Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.\n\nThe methods of access for epidural injections are characterized as transforaminal, interlaminar, or caudal. Caudal epidural injections (CEI) are often utilized as a diagnostic or therapeutic tool in a range of lumbosacral-originating spinal pain problems, and they are especially useful in patients with complicated lumbar epidural access diseases, such as post laminectomy syndrome. It is regarded as a very simple treatment in the realm of interventional pain management, and it is also recognized to have a reduced risk of inadvertent Dural puncture than other epidural techniques", 'detailedDescription': "Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.\n\nMajor lumbosacral surgery results in considerable postoperative discomfort that normally lasts at least three days. According to several research, the most discomfort occurs in the first four postoperative hours and gradually decreases by the third postoperative day. Efficient and safe postoperative analgesic treatments following lumbosacral surgery are useful for early recovery and hence required.\n\nTraditional caudal epidural injections, on the other hand, pose a potential risk of epidural venous plexus or dura penetration, with the incidence of accidental intravascular injections, as confirmed by contrast enhanced fluoroscopy, ranging from 11 to 42% in patients who had received caudal epidural injections. Furthermore, there have been a few instances of unintended Dural puncture during the caudal approach because of an unusually low Dural sac termination in the sacral canal.\n\nSuch complications of intravascular and intrathecal drug injections might result in systemic toxicity of local anesthetics and complete spinal anesthesia. Thus, ultrasonography (US) can be utilized to guide caudal injections, increasing the efficacy of pain treatment while decreasing the risk of complications and incorrect injections. Previous investigations shown the feasibility of using ultrasound to locate the sacral hiatus and guide the needle into the caudal epidural area, with a reported success rate of 100%.\n\nAnother technique for postoperative pain relief is the Erector spinae plane block (ESPB), which was introduced in 2016. It is a relatively new regional anesthesia technique in which local anesthetic is injected into the fascial plane between the transverse process of the vertebra and the erector spinae muscles. It has acquired favor in perioperative analgesia for a variety of surgical procedures, including breast, thoracic, abdominal, and lumbar spine operations.\n\nThe addition of US to ESPB allows the needle to be guided to efficiently deposit the anesthetic agents deep to the erector spinae muscle, resulting in the blockage of the ventral and dorsal rami of many spinal neurons, boosting the efficiency of pain control."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing lumbosacral spine surgeries from (L4-L5) level to end of spinal cord.\n* American society of anesthesiologists' classification (ASA) I \\& II.\n\nExclusion Criteria:\n\n* Patient's refusal.\n* History of any previous back surgeries.\n* History of any spinal cord deformities e.g., Scoliosis, Lordosis, Kyphosis, Ankylosing Spondylitis\n* Bleeding disorders (platelets count \\< 80,000; International normalized ratio \\>1.4; PC\\< 70%) and coagulopathies.\n* Skin lesion, wounds, or infection at the injection site.\n* Known allergy to local anesthetic drugs.\n* Peripheral and Central Neuropathy.\n* Patients with pre-operative opioid consumption.\n* Chronic opioids or analgesics users."}, 'identificationModule': {'nctId': 'NCT06336161', 'briefTitle': 'Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection in Lumbosacral Spine Surgeries for Postoperative Pain Management', 'orgStudyIdInfo': {'id': 'ESPB versus CEI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A ( Erector Spinae Plane Block)', 'description': 'About 40 patients who will be subjected to Ultrasound-Guided Erector Spinae Plane Block.for Postoperative Pain Management', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Caudal Injection)', 'description': 'About 40 patients who will be subjected to Ultrasound-Guided Caudal Injection in Lumbosacral Spine Surgeries for Postoperative Pain Management', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['propofol 2Mg/Kg'], 'description': 'to compare between Ultrasound-Guided ESPB and Ultrasound-Guided CEI for postoperative pain relief in patients who underwent lumbosacral surgeries.', 'armGroupLabels': ['Group A ( Erector Spinae Plane Block)', 'Group B (Caudal Injection)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Khalil, Resident', 'role': 'CONTACT', 'email': 'khalil.mohamed24mkh@gmail.com', 'phone': '+201001297071'}], 'facility': 'Al-Azhar University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Khalil, Resident', 'role': 'CONTACT', 'email': 'khalil.mohamed24mkh@gmail.com', 'phone': '+201001297071'}, {'name': 'Othman Yahia, Lecturer', 'role': 'CONTACT', 'email': 'khalil.mohamed24mkh@gmail.com', 'phone': '+201001297071'}], 'overallOfficials': [{'name': 'Tarek Monir, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Al-Azhar University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cairo,Egypt', 'investigatorFullName': 'Mohamed Khalil Elsayed Khalil', 'investigatorAffiliation': 'Al-Azhar University'}}}}