Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT06965933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-11', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time before emergency pain relief (opioid).', 'timeFrame': '24 hours postoperatively', 'description': 'Time before emergency pain relief (opioid).'}], 'secondaryOutcomes': [{'measure': 'the need for opioids in the postoperative period within 24 hours', 'timeFrame': '24 hours', 'description': 'the need for opioids in the postoperative period within 24 hours (of the start of anesthesia)'}, {'measure': 'pain level assessment using pain scales (Wong-Baker Faces Pain Rating Scale)', 'timeFrame': '24 hours postoperatively', 'description': 'use Wong-Baker Faces Pain Rating Scale (postoperative period)\n\nThe Wong-Baker Faces Pain Rating Scale is used for general assessment of pain intensity in adult patients and children over 3 years of age.\n\nThe scale consists of 6 faces, ranging from laughing (no pain) to crying (unbearable pain).\n\nEach face corresponds to a certain number of points:\n\n0 points - a happy smiling face, means no pain (No Hurt); 2 points - a slight smile on the face, means slight soreness (Hurts Little Bit); 4 points - neutral facial expression, means slight pain (Hurts Little More); 6 points - facial expression with slightly furrowed eyebrows, means average pain (Hurts Even More); 8 points - a facial expression with heavily furrowed eyebrows means severe pain (Hurts a Whole Lot); 10 points - a crying, unhappy expression means excessive unbearable pain (Hurts Worst).'}, {'measure': 'assessment of intraoperative analgesia quality (pulse)', 'timeFrame': 'during surgery', 'description': 'pulse monitoring during surgery'}, {'measure': 'assessment of intraoperative analgesia quality (BP)', 'timeFrame': 'during surgery', 'description': 'Blood pressure monitoring during surgery'}, {'measure': 'Complications associated with intravenous lidocaine infusion (general toxic effects on the cardiovascular and central nervous systems)', 'timeFrame': '24 hours'}, {'measure': 'Complications associated with spinal straightening plane block (ESPB)', 'timeFrame': '24 hours', 'description': 'Complications: neurological, bleeding, hematoma, infection.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESPB', 'Erector Spinae Plane Block', 'Lidocaine', 'Regional Anesthesia', 'Lidocaine infusion', 'Spinal Surgery'], 'conditions': ['Regional Anesthesia', 'Lidocaine Infusion']}, 'descriptionModule': {'briefSummary': 'Testing the hypothesis that in children undergoing spinal surgery, ESP-block will increase the time to emergency anesthesia in the postoperative period compared with intravenous lidocaine infusion.', 'detailedDescription': 'Interventions for congenital or acquired spinal anomalies are usually voluminous and traumatic, which causes a high level of pain stimulation during the perioperative period. Thus, the problem of pain in spinal surgery is extremely important and is one of the main components of successful treatment.\n\nCombined anesthesia using regional techniques (local anesthesia is added to general anesthesia) can be a significant alternative to performing traditional combined anesthesia with high doses of opioids (narcotic painkillers with undesirable side effects). It allows you to follow the principles of multimodal analgesia, with the possibility of rapid recovery of the patient in the postoperative period.\n\nThe use of ESPB (spinal straightening plane blockade) in vertebrology has currently been studied only in adult patients. ESPB is effective and safe for postoperative pain relief after lumbar spine surgery. ESPB can reduce the consumption of opioids (narcotic painkillers) after surgery, increase patient satisfaction, and shorten the length of hospitalization.\n\nCurrently, the use of the local anesthetic lidocaine as a medicinal agent for intravenous infusion in children, as an alternative to narcotic anesthesia, is also being actively discussed.\n\nA large number of studies indicate the effectiveness of intravenous lidocaine infusion for perioperative anesthesia in adult patients. In pediatric practice, this technique is not widely used due to the lack of evidence base for efficacy and safety.\n\nIntravenous infusion of lidocaine consistently improves analgesic parameters in the adult and pediatric populations in the first 24 hours, while an effective decrease in the consumption of narcotic painkillers is noted by 48 hours.\n\nIntravenous lidocaine has demonstrated antineuropathic, antihyperalgesic and anti-inflammatory effects and is a new method. Numerous studies in adults have demonstrated the beneficial effects of intravenous lidocaine, including improved pain relief with reduced postoperative use of narcotic painkillers, earlier activation, and shorter length of stay in the intensive care unit. To date, the dose ranges studied in the pediatric population have not been associated with serious side effects, and current evidence suggests that intravenous lidocaine administration will be well tolerated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Elective surgery on the thoracic and lumbosacral spine. 2. Signed informed consent to participate in the study; 3. Age 3-17 years.\n\nExclusion Criteria:\n\n1. Contraindications to the use of local anesthetics;\n2. Operations on the cervical spine;\n3. Contraindications to performing ESPB;\n4. The patient's refusal to participate in the study."}, 'identificationModule': {'nctId': 'NCT06965933', 'briefTitle': 'Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children', 'organization': {'class': 'OTHER', 'fullName': 'Saint Petersburg State University, Russia'}, 'officialTitle': 'Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children', 'orgStudyIdInfo': {'id': 'SaintPetersburgSU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blockade of the plane straightening the spine (Erector Spinae Plane Block, ESPB).', 'interventionNames': ['Procedure: ESP block group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV Lidocaine', 'interventionNames': ['Drug: IV Lidocaine']}], 'interventions': [{'name': 'ESP block group', 'type': 'PROCEDURE', 'description': 'The patient will undergo an ESP blockade under the control of ultrasound during the implementation of anesthetic support. A local anesthetic will be injected into the fascial space of the muscles straightening the spine: ropivacaine 0.375%, 3 mg / kg, on both sides.', 'armGroupLabels': ['Blockade of the plane straightening the spine (Erector Spinae Plane Block, ESPB).']}, {'name': 'IV Lidocaine', 'type': 'DRUG', 'description': 'During the implementation of anesthetic support, the patient will receive a constant intravenous infusion of lidocaine: a loading dose of 1.5 mg/kg/ h (1 hour), followed by an infusion of 1 mg/kg/h for 24 hours during the perioperative period.', 'armGroupLabels': ['IV Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '190121', 'city': 'Saint Petersburg', 'state': 'Sankt-Peterburg', 'country': 'Russia', 'contacts': [{'name': 'Maxim Sergeevich Monastyrnyi, Medicinae Doctor (M.D.)', 'role': 'CONTACT', 'email': 'doctor.maksimsergeevich@gmail.com', 'phone': '+79818870151'}, {'name': 'Maxim Sergeevich Monastyrnyi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SaintPetersburgSU', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Maxim Sergeevich Monastirniy', 'role': 'CONTACT', 'email': 'doctor.maksimsergeevich@gmail.com', 'phone': '+79818870151'}], 'overallOfficials': [{'name': 'Maxim Sergeevich Monastirniy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Petersburg State University, Russia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'By an inappropriate request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Petersburg State University, Russia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist-Intensivist, Research Physician', 'investigatorFullName': 'Maxim Monastirniy', 'investigatorAffiliation': 'Saint Petersburg State University, Russia'}}}}