Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT05938959
Status:
UNKNOWN
Last Update Posted:
2023-10-13
First Post:
2023-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients will be randomly allocated to receive ultrasound-guided ESP block with 0,2% ropivacaine or ESP block with the sham block by computer software 1:1. A researcher who will not be involved in the study will prepare the randomization list and concealed group assignments in consecutively numbered, sealed, opaque envelopes. A consultant anesthesiologist will follow management to open the envelopes shortly before the nerve block performance to reveal the group allocation and perform the procedure according to the assignment. The surgeon, patients, and anesthesia team will be masked to the study group. Group blinding unmasking will only occur once the statistical analysis is complete.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Numerical Rating Scale', 'timeFrame': '30 minutes after surgery', 'description': 'Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)'}, {'measure': 'Pain Numerical Rating Scale', 'timeFrame': '60 minutes after surgery', 'description': 'Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)'}, {'measure': 'Pain Numerical Rating Scale', 'timeFrame': '90 minutes after surgery', 'description': 'Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)'}, {'measure': 'Pain Numerical Rating Scale', 'timeFrame': '120 minutes after surgery', 'description': 'Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)'}, {'measure': 'Pain Numerical Rating Scale', 'timeFrame': '6 hours after surgery', 'description': 'Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)'}, {'measure': 'Pain Numerical Rating Scale', 'timeFrame': '12 hours hours after surgery', 'description': 'Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)'}, {'measure': 'Pain Numerical Rating Scale', 'timeFrame': '24 hours after surgery', 'description': 'Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)'}, {'measure': 'Pain Numerical Rating Scale', 'timeFrame': '48 hours after surgery', 'description': 'Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)'}], 'secondaryOutcomes': [{'measure': 'neutrophil/lymphocyte ratio', 'timeFrame': '12 hours and 24 hours after surgery', 'description': 'neutrophil/lymphocyte ratio'}, {'measure': 'platelet/lymphocyte ratio', 'timeFrame': '12 hours and 24 hours after surgery', 'description': 'platelet/lymphocyte ratio'}, {'measure': 'Nausea or Vomiting', 'timeFrame': 'during first 24 hours after surgery', 'description': 'presence or absence'}, {'measure': 'total opioid consumption', 'timeFrame': 'Day 1 after surgery', 'description': 'intravenous milligrams of morphine equivalents'}, {'measure': 'total opioid consumption', 'timeFrame': 'Day 2 after surgery', 'description': 'intravenous milligrams of morphine equivalents'}, {'measure': 'total opioid consumption', 'timeFrame': 'Day 3 after surgery', 'description': 'intravenous milligrams of morphine equivalents'}, {'measure': 'total opioid consumption', 'timeFrame': 'Day 4 after surgery', 'description': 'intravenous milligrams of morphine equivalents'}, {'measure': 'total opioid consumption', 'timeFrame': 'Day 5 after surgery', 'description': 'intravenous milligrams of morphine equivalents'}, {'measure': 'total opioid consumption', 'timeFrame': 'Day 6 after surgery', 'description': 'intravenous milligrams of morphine equivalents'}, {'measure': 'total opioid consumption', 'timeFrame': 'Day 7 after surgery', 'description': 'intravenous milligrams of morphine equivalents'}, {'measure': 'Motor Evoked Potential amplitude', 'timeFrame': 'up to seven days prior to the correction of scoliosis', 'description': 'Motor Evoked Potentials durring surgery'}, {'measure': 'Motor Evoked Potential amplitude', 'timeFrame': 'up to 24 weeks following the correction of scoliosis', 'description': 'Motor Evoked Potentials during surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain management', 'peripheral nerve block', 'erector spinae plane block', 'euromonitoring'], 'conditions': ['Scoliosis Idiopathic']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the effect of the interfacial plane blocks on the pain level, the course of postoperative rehabilitation, and its anti-inflammatory analgesic effect.', 'detailedDescription': 'This study evaluates the analgesic efficacy in adolescents of bilevel, bilateral erector spinae plane (ESP) blocks after posterior spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 10-18 years old\n* pediatric patients who will undergo the surgical correction of idiopathic scoliosis\n\nExclusion Criteria:\n\n* a history of chronic pain (use of gabapentin/pregabalin for \\> 3 months or opioid use \\> 1 repeated opioid prescription in the last three months)\n* morbid obesity (BMI \\> 99th percentile)\n* previous surgery\n* back abnormalities\n* infection at block application area\n* coagulopathy'}, 'identificationModule': {'nctId': 'NCT05938959', 'acronym': 'ESPB', 'briefTitle': 'Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.', 'orgStudyIdInfo': {'id': '3/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sham group', 'description': 'Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% Normal Saline', 'interventionNames': ['Drug: Sham block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ESPB group', 'description': 'Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg)', 'interventionNames': ['Drug: ESPB']}], 'interventions': [{'name': 'Sham block', 'type': 'DRUG', 'otherNames': ['0,9% normal saline'], 'description': 'Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% normal saline', 'armGroupLabels': ['Sham group']}, {'name': 'ESPB', 'type': 'DRUG', 'otherNames': ['0,2% ropivacaine'], 'description': 'Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg)', 'armGroupLabels': ['ESPB group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-545', 'city': 'Poznan', 'state': 'Wielkopolska', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Tomasz Kotwicki, Profesor', 'role': 'CONTACT', 'email': 'kckod@ump.edu.pl', 'phone': '+48618310157'}], 'facility': 'Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Grzegorz Kowalski, PhD', 'role': 'CONTACT', 'email': 'gkowalski@ump.edu.pl'}], 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Magorzata Domagalska, Ph.D.', 'role': 'CONTACT', 'email': 'm.domagalska@icloud.com', 'phone': '0048608762068'}], 'overallOfficials': [{'name': 'Tomasz Kotwicki, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Poznań University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}