Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT04797559
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2021-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SZMN Blocks for Pain Control in Pediatric Patients Undergoing T&A
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Both groups will receive a small circular band-aid on their temples.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients in the interventional group will receive a total of 5 mL of local anesthetic bilaterally near their temples.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2021-03-10', 'studyFirstSubmitQcDate': '2021-03-10', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Surgical Pain', 'timeFrame': '7 days after surgery', 'description': 'Patients will rate their pain on a 0-10 scale'}], 'secondaryOutcomes': [{'measure': 'Opioid Consumption', 'timeFrame': "1-3 hours after surgery (during the patient's stay in post-anesthesia care unit)", 'description': 'Pain medications consumed by patients will be collected'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SZMN Block', 'Tonsillectomy and Adenoidectomy', 'Regional Anesthesia'], 'conditions': ['Postoperative Pain', 'Opioid Use']}, 'referencesModule': {'references': [{'pmid': '24525630', 'type': 'BACKGROUND', 'citation': 'Chiono J, Raux O, Bringuier S, Sola C, Bigorre M, Capdevila X, Dadure C. Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. Anesthesiology. 2014 Jun;120(6):1362-9. doi: 10.1097/ALN.0000000000000171.'}, {'pmid': '18983373', 'type': 'RESULT', 'citation': 'Grainger J, Saravanappa N. Local anaesthetic for post-tonsillectomy pain: a systematic review and meta-analysis. Clin Otolaryngol. 2008 Oct;33(5):411-9. doi: 10.1111/j.1749-4486.2008.01815.x.'}, {'pmid': '38780948', 'type': 'DERIVED', 'citation': 'Lin C, Abboud S, Zoghbi V, Kasimova K, Thein J, Meister KD, Sidell DR, Balakrishnan K, Tsui BCH. Suprazygomatic Maxillary Nerve Blocks and Opioid Requirements in Pediatric Adenotonsillectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Jul 1;150(7):564-571. doi: 10.1001/jamaoto.2024.1011.'}]}, 'descriptionModule': {'briefSummary': 'The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures, however, have not been studied for patients undergoing tonsillectomy and adenoidectomy (T\\&A) procedures. The goals of this study are to determine if SZMN block can be utilized for pain control and decrease morbidity in pediatric patients undergoing T\\&A.', 'detailedDescription': 'Patients between 6 months and 18 years undergoing T\\&A surgical procedures will be reviewed for potential study enrollment. If participants agree to participate, they will be randomized into either the suprazygomatic maxillary nerve (SZMN) block treatment cohort or the control cohort i.e standard of care.\n\nAfter anesthesia induction, patients randomized into the SZMN- treatment group will receive a bilateral single injection SZMN block under general anesthesia in the operating room. The injection will occur near the temples above the cheek bones.\n\nParticipants enrolled into the control group will receive standard of care with no changes to their anesthetic or surgical care. Both groups will be asked for their verbal pain scores in the PACU and we will track their opioid consumption throughout the next few days after their procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 0-18\n* Give consent/parental consent to participate in study\n* Patients undergoing tonsillectomy and adenoidectomy\n\nExclusion Criteria:\n\n* Participants who do not consent or have parental consent\n* Patients who are clinically unstable or require urgent/emergent intervention\n* Patients under age 6 months'}, 'identificationModule': {'nctId': 'NCT04797559', 'acronym': 'SZMN', 'briefTitle': 'SZMN Blocks for Pain Control in Pediatric Patients Undergoing T&A', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Suprazygomatic Maxillary Nerve (SZMN) Blocks for Pain Control in Pediatric Patients Undergoing T&A: Randomized Controlled Trial ]', 'orgStudyIdInfo': {'id': '60450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SZMN Treatment Group', 'description': 'Patients randomized into the SZMN-treatment group will receive a bilateral single injection SZMN block under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthestic per side.', 'interventionNames': ['Procedure: SZMN Block']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients in this group will receive the standard of care for T\\&A procedures within the pediatric population.'}], 'interventions': [{'name': 'SZMN Block', 'type': 'PROCEDURE', 'description': 'Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally near the temples of the patient', 'armGroupLabels': ['SZMN Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucille Packard Children's Hospital", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Ban C Tsui, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor'}, {'name': 'Carole Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatric Anesthesiologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chi-Ho Ban Tsui', 'investigatorAffiliation': 'Stanford University'}}}}