Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-05 @ 8:03 PM
Study NCT ID:
NCT05944393
Status:
UNKNOWN
Last Update Posted:
2023-07-13
First Post:
2023-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Subjects will be randomized to one of two groups with a computer-generated arm assignment. The sealed envelopes will be opened immediately prior to nerve block. One group will receive a ESP block and the other will receive a placebo block. The provider performing the block will not be blinded, however all other members of the care team, the patient, and the investigator collecting data will be blinded to the randomization.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'after being informed about the study and potential risks. All patients giving written consent will be randomized in a double-blind manner into 2 groups each one containing 25 patients, ESP group (n =25 ): The patients will receive Erector Spine Plane Block (ESP Block) after induction of general anesthesia.\n\nControl group (n =25 ): The patients will receive a placebo block after induction of general anesthesia'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-05', 'studyFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2023-07-05', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'Within 30 minutes of emergence from anesthesia', 'description': 'NRS (numerical rating scale) score (0- no pain to 10 worst pain)'}, {'measure': 'pain score - 60 minutes', 'timeFrame': 'Within 60 minutes of emergence from anesthesia', 'description': 'NRS (numerical rating scale) score (0- no pain to 10 worst pain)'}, {'measure': 'pain score - 90 minutes', 'timeFrame': 'Within 90 minutes of emergence from anesthesia', 'description': 'NRS (numerical rating scale) score (0- no pain to 10 worst pain)'}, {'measure': 'pain score - 120 minutes', 'timeFrame': 'Within 120 minutes of emergence from anesthesia', 'description': 'NRS (numerical rating scale) score (0- no pain to 10 worst pain)'}, {'measure': 'pain score - 6 hours', 'timeFrame': 'Within 6 hours of emergence from anesthesia', 'description': 'NRS (numerical rating scale) score (0- no pain to 10 worst pain)'}, {'measure': 'pain score - 12 hours', 'timeFrame': 'Within 12 hours of emergence from anesthesia', 'description': 'NRS (numerical rating scale) score (0- no pain to 10 worst pain)'}, {'measure': 'pain score - 24 hours', 'timeFrame': 'Within 24 hours of emergence from anesthesia', 'description': 'NRS (numerical rating scale) score (0- no pain to 10 worst pain)'}, {'measure': 'pain score - 48 hours', 'timeFrame': 'Within 48 hours of emergence from anesthesia', 'description': 'NRS (numerical rating scale) score (0- no pain to 10 worst pain)'}], 'secondaryOutcomes': [{'measure': 'total opioid consumption within first 24 hours', 'timeFrame': 'Second day following the procedure', 'description': 'Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is \\<4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.'}, {'measure': 'opioid consumption - 48 hours', 'timeFrame': 'Within 48 hours of emergence from anesthesia', 'description': 'Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is \\<4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.'}, {'measure': 'Nausea and Vomiting', 'timeFrame': 'Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (0-48 hours postoperativly)', 'description': 'This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit.'}, {'measure': 'NLR -12 hours', 'timeFrame': '12 hours postoperatively', 'description': 'neutrophil/limphocyte ratio'}, {'measure': 'PLR -12 hours', 'timeFrame': '12 hours postoperatively', 'description': 'platelet/limphocyte ratio'}, {'measure': 'NLR - 24 hours', 'timeFrame': '12 hours postoperatively', 'description': 'neutrophil/limphocyte ratio'}, {'measure': 'PLR - 24 hours', 'timeFrame': '12 hours postoperatively', 'description': 'platelet/limphocyte ratio'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spine plane block', 'neuromonitoring', 'pain management', 'multimodal analgesia'], 'conditions': ['Scoliosis', 'Regional Anesthesia', 'Pediatric Anesthesia', 'Orthopedic Disorder of Spine']}, 'descriptionModule': {'briefSummary': 'Postoperative pain after scoliosis correction surgery is severe and usually requires long-term intravenous opioid therapy. Local anesthetic options are limited and include intrathecal opioids and epidural analgesia. However, they are rarely used due to side effects and inconsistent efficacy. The investigators describe an opioid-sparing multimodal analgesia regimen with bilateral erector spinae plane blocks.', 'detailedDescription': 'Posterior spinal fusion for scoliosis correction is extremely painful and usually requires long-term, high-dose opioid use for adequate perioperative analgesia. Neuromonitoring, i.e., motor-evoked and somatosensory-evoked potentials (SSEPs), are the current gold standard for preventing neurological damage. Local anesthesia is essential to multimodal analgesia, but options are limited. Intrathecal or epidural opioid injections of local anesthetics have been reported but are rarely used due to logistical complexity, side effects, and inconsistent analgesic efficacy. The erector spinae plane (ESP) block was first described in 2016 for thoracic neuropathic pain. It is a new interfacial plane technique. Easy to perform on patients without spinal deformities. It was successfully used for surgery in adults. However, even with ultrasound guidance, identifying bone markers in scoliosis patients is challenging. The investigators will treat patients for scoliosis with single-shot bilateral ESP blocks. The investigators aim to provide effective perioperative pain control and achieve intraoperative hemodynamic stability without compromising neuromonitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\< 18 years old undergoing scoliosis surgery\n\nExclusion Criteria:\n\n* refusal to participate\n* \\> 18 yo\n* Chronic opioid use\n* localized infection'}, 'identificationModule': {'nctId': 'NCT05944393', 'briefTitle': 'Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery', 'orgStudyIdInfo': {'id': '673/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESB block', 'description': 'Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0.2% ropivacaine per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,2% Ropivacaine. The needle is withdrawn, and the needle entry site is wiped clean.', 'interventionNames': ['Drug: Ropivacaine 0.2% Injectable Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo block', 'description': 'Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0,9% normal saline per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,9% normal saline. The needle is withdrawn, and the needle entry site is wiped clean.', 'interventionNames': ['Drug: Normal saline 0.9% Injectable Solution']}], 'interventions': [{'name': 'Ropivacaine 0.2% Injectable Solution', 'type': 'DRUG', 'description': 'Ultrasound-guided Erector Spine Plane block with 10 mL 0.5% ropivacaine', 'armGroupLabels': ['ESB block']}, {'name': 'Normal saline 0.9% Injectable Solution', 'type': 'DRUG', 'description': 'Ultrasound-guided Erector Spine Plane block with 10 mL 0.9% normal saline', 'armGroupLabels': ['Placebo block']}]}, '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}}], 'centralContacts': [{'name': 'Małgorzata Domagalska, PhD', 'role': 'CONTACT', 'email': 'm.domagalska@icloud.com', 'phone': '608762068'}, {'name': 'Małgorzata Domagalska', 'role': 'CONTACT', 'email': 'm.domagalska@icloud.com'}], 'overallOfficials': [{'name': 'Małgorzata Domagalska, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Palliative Medicine, University of Medical Sciences'}, {'name': 'Tomasz Kotwicki, Profesor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will become available after completing the study- December 2024', 'ipdSharing': 'YES', 'description': 'The data presented in this study are available on request from the corresponding author.', 'accessCriteria': 'The data presented in this study are available on request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}