Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-02-01 @ 2:42 PM
Study NCT ID:
NCT02647892
Status:
TERMINATED
Last Update Posted:
2023-08-21
First Post:
2015-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D017693', 'term': 'Sodium Bicarbonate'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'IRB protocol administratively closed, Continuing Review or Study Completion Report not submitted', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2015-12-17', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Injection pain', 'timeFrame': '6 months', 'description': 'numeric pain scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Local Anesthesia']}, 'referencesModule': {'references': [{'pmid': '25991379', 'type': 'BACKGROUND', 'citation': 'Skarsvag TI, Wago KJ, Tangen LF, Lundbom JS, Hjelseng T, Ballo S, Finsen V. Does adjusting the pH of lidocaine reduce pain during injection? J Plast Surg Hand Surg. 2015 Oct;49(5):265-267. doi: 10.3109/2000656X.2015.1047780. Epub 2015 May 19.'}, {'pmid': '2240750', 'type': 'BACKGROUND', 'citation': 'Bartfield JM, Gennis P, Barbera J, Breuer B, Gallagher EJ. Buffered versus plain lidocaine as a local anesthetic for simple laceration repair. Ann Emerg Med. 1990 Dec;19(12):1387-9. doi: 10.1016/s0196-0644(05)82603-4.'}, {'pmid': '9672449', 'type': 'BACKGROUND', 'citation': 'Colaric KB, Overton DT, Moore K. Pain reduction in lidocaine administration through buffering and warming. Am J Emerg Med. 1998 Jul;16(4):353-6. doi: 10.1016/s0735-6757(98)90126-7.'}, {'pmid': '1430977', 'type': 'BACKGROUND', 'citation': 'Orlinsky M, Hudson C, Chan L, Deslauriers R. Pain comparison of unbuffered versus buffered lidocaine in local wound infiltration. J Emerg Med. 1992 Jul-Aug;10(4):411-5. doi: 10.1016/0736-4679(92)90269-y.'}, {'pmid': '8136599', 'type': 'BACKGROUND', 'citation': 'Matsumoto AH, Reifsnyder AC, Hartwell GD, Angle JF, Selby JB Jr, Tegtmeyer CJ. Reducing the discomfort of lidocaine administration through pH buffering. J Vasc Interv Radiol. 1994 Jan-Feb;5(1):171-5. doi: 10.1016/s1051-0443(94)71478-0.'}, {'type': 'BACKGROUND', 'citation': 'Machin D, Campbell M, Fayers P, Pinol A. 1997. Sample Size Tables for Clinical Studies, 2nd Edition. Blackwell Science. Malden MA.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia.', 'detailedDescription': 'Once the site is chosen, the skin will be anesthetized as usual. This study will utilize a commercially prepared 1% lidocaine solution mixed with standard sodium bicarbonate. A total of 10 mL will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology\n\nExclusion Criteria:\n\n* Patients requiring sedation\n* Patients with altered mental status\n* Children\n* Patients allergic to lidocaine or sodium bicarbonate'}, 'identificationModule': {'nctId': 'NCT02647892', 'briefTitle': 'Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia', 'orgStudyIdInfo': {'id': '0787-15-EP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A', 'description': '10 mg/mL lidocaine; Frequency: 1', 'interventionNames': ['Drug: lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': '9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1', 'interventionNames': ['Drug: lidocaine', 'Drug: sodium bicarbonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm C', 'description': '7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1', 'interventionNames': ['Drug: lidocaine', 'Drug: sodium bicarbonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm D', 'description': '5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1', 'interventionNames': ['Drug: lidocaine', 'Drug: sodium bicarbonate']}], 'interventions': [{'name': 'lidocaine', 'type': 'DRUG', 'otherNames': ['xylocaine'], 'description': 'local anesthesia', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C', 'Arm D']}, {'name': 'sodium bicarbonate', 'type': 'DRUG', 'description': 'additional drug added to lidocaine', 'armGroupLabels': ['Arm B', 'Arm C', 'Arm D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Joseph McBride, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}