Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT03036605
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2017-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2017-01-27', 'lastUpdatePostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic consumption', 'timeFrame': 'Postoperative 24 hours', 'description': 'Analgesic consumption first 24 hours'}], 'secondaryOutcomes': [{'measure': 'Visual analog pain score', 'timeFrame': 'postoperative first hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative second hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 4th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 8th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 12th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 24th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexamethasone', 'bupivacaine', 'nasal surgery', 'nasal packing'], 'conditions': ['Nasal Surgery']}, 'referencesModule': {'references': [{'pmid': '26118324', 'type': 'BACKGROUND', 'citation': 'Sahin C, Aras HI. Effect on patient anxiety of lidocaine infiltration into nasal packing after septoplasty: prospective, controlled study. J Laryngol Otol. 2015 Aug;129(8):784-7. doi: 10.1017/S0022215115001644. Epub 2015 Jun 29.'}, {'pmid': '20643015', 'type': 'BACKGROUND', 'citation': 'Yilmaz S, Kocaman Akbay B, Yildizbas S, Guclu E, Yaman H, Yalcin Sezen G. Efficacy of topical levobupivacaine in control of postoperative pain after septoplasty. J Otolaryngol Head Neck Surg. 2010 Aug;39(4):454-7.'}, {'pmid': '21799397', 'type': 'BACKGROUND', 'citation': 'De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.'}, {'pmid': '28033159', 'type': 'BACKGROUND', 'citation': 'Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.'}]}, 'descriptionModule': {'briefSummary': 'Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis, prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to pain, therefore the most common problems after surgery are postoperative pain and anxiety during removal of the nasal packing. Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics, local anesthetics infiltration into nasal packing).\n\nGlucocorticoids have been used as an adjuvant in the management of acute postoperative pain. Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces postoperative nausea and vomiting incidance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologist's physiologic state I-II patients undergoing nasal surgery\n\nExclusion Criteria:\n\n* chronic pain\n* bleeding disorders\n* renal or hepatic insufficiency\n* patients on chronic non-steroidal anti-inflammatory medications\n* emergency cases"}, 'identificationModule': {'nctId': 'NCT03036605', 'briefTitle': 'The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Postoperative Analgesic Effect of Dexamethasone Added to Topical Bupivacaine in Endoscopic Nasal Surgery', 'orgStudyIdInfo': {'id': 'Ataturk University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Bupivacaine', 'description': '4 ml %0.5 bupivacaine and 1 ml %0.9 NaCl infiltration into nasal packing to both sides', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Bupivacaine+Dexamethasone', 'description': '4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Bupivacaine only'], 'description': '%0.5 bupivacaine', 'armGroupLabels': ['Group Bupivacaine', 'Group Bupivacaine+Dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Bupivacaine plus dexamethasone'], 'description': '8 mg Dexamethasone', 'armGroupLabels': ['Group Bupivacaine+Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Erzurum', 'state': 'Yakutiye', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Ahmet Murat Yayik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ahmet Murat Yayik', 'investigatorAffiliation': 'Ataturk University'}}}}