Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-03 @ 5:09 PM
Study NCT ID:
NCT02751268
Status:
UNKNOWN
Last Update Posted:
2016-04-29
First Post:
2016-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-27', 'studyFirstSubmitDate': '2016-04-24', 'studyFirstSubmitQcDate': '2016-04-24', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergence agitation', 'timeFrame': '2 hours after surgery', 'description': 'Emergence agitation is measured by Riker Sedation-Agitated Scale (RASS) and is defined as RASS=5-7'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '2, 8, 24, 48 hours after surgery', 'description': '0-10 numerical rating scale (NRS) : from 0 = no pain to 10 = worst pain imaginable'}, {'measure': 'Patient satisfaction', 'timeFrame': '48 hours after surgery', 'description': '1-5 scale (1: very unsatisfactory, 2: rather unsatisfactory, 3: fair, 4: rather satisfactory, 5: very satisfactory)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infraorbital nerve block', 'infratrochlear nerve block', 'septorhinoplasty', 'general anesthesia', 'postoperative analgesia'], 'conditions': ['Emergence Agitation', 'Pain']}, 'referencesModule': {'references': [{'pmid': '25729495', 'type': 'BACKGROUND', 'citation': 'Kim HJ, Kim DK, Kim HY, Kim JK, Choi SW. Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):46-51. doi: 10.3342/ceo.2015.8.1.46. Epub 2015 Feb 3.'}, {'pmid': '26549134', 'type': 'BACKGROUND', 'citation': 'Boselli E, Bouvet L, Augris-Mathieu C, Begou G, Diot-Junique N, Rahali N, Vertu-Ciolino D, Gerard C, Pivot C, Disant F, Allaouchiche B. Infraorbital and infratrochlear nerve blocks combined with general anaesthesia for outpatient rhinoseptoplasty: A prospective randomised, double-blind, placebo-controlled study. Anaesth Crit Care Pain Med. 2016 Feb;35(1):31-36. doi: 10.1016/j.accpm.2015.09.002. Epub 2015 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty are effective in preventing emergence agitation.', 'detailedDescription': 'Emergence agitation is a postanesthetic phenomenon characterized as confusion, disorientation and violent behavior. Although its etiology is not well understood, risk factors associated with the condition include pain and ENT (ear, nose and throat) surgery. Bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty is effective in treating postoperative pain. The investigators have designed this study to evaluate the effect of infraorbital and infratrochlear nerve block on emergence agitation in patients undergoing septorhinoplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Septorhinoplasty\n* American Society of Anesthesiologists (ASA) classification I-II\n* Written informed consent\n\nExclusion Criteria:\n\n* ASA classification greater than III\n* Allergy to ropivacaine\n* Incapability to give consent\n* Chronic pain\n* Coagulopathy'}, 'identificationModule': {'nctId': 'NCT02751268', 'briefTitle': 'Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Armed Forces Hampyeong Hospital'}, 'officialTitle': 'Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AFMC-16028-IRB-16-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'placebo for the realization of infraorbital and infratrochlear block', 'interventionNames': ['Drug: Normal Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine', 'description': 'ropivacaine for the realization of infraorbital and infratrochlear block', 'interventionNames': ['Drug: Ropivacaine']}], 'interventions': [{'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Bilateral infraorbital and infratrochlear nerve block before general anesthesia with normal saline', 'armGroupLabels': ['Control']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'Bilateral infraorbital and infratrochlear nerve block before general anesthesia with 0.5% ropivacaine', 'armGroupLabels': ['Ropivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57116', 'city': 'Geumgyeri', 'state': 'Haebo-myeon, Hampyeong-gun, Jeollanam-do', 'country': 'South Korea', 'facility': 'Armed Forces Hampyeong Hospital', 'geoPoint': {'lat': 36.26696, 'lon': 127.87048}}], 'overallOfficials': [{'name': 'Hoon Choi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Armed Forces Hampyeong Hostpital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armed Forces Hampyeong Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. Department of Anesthesiology and Pain Medicine, Armed Forces Hampyeong Hospital', 'investigatorFullName': 'Hoon Choi', 'investigatorAffiliation': 'Armed Forces Hampyeong Hospital'}}}}