Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-03 @ 12:41 AM
Study NCT ID:
NCT03206320
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2017-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Lidocaine for Needle Insertion and Injection Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2017-06-22', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Needle insertion pain', 'timeFrame': 'Immediately at the time the needle is inserted through the skin', 'description': 'Pain rating (VAS)'}, {'measure': 'Injection pain', 'timeFrame': 'Immediately at the end of the block', 'description': 'Pain rating (VAS)'}], 'secondaryOutcomes': [{'measure': 'Fearfulness', 'timeFrame': 'Just before the nerve block', 'description': 'Likert scale from "1" (no fear) to "5" (very fearful)'}, {'measure': 'Overall discomfort', 'timeFrame': 'Immediately at the end of the block', 'description': 'Verbal rating scale from "0" (more comfortable/less painful than expected) to "10" (less comfortable/more painful than expected)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Needle Insertion and Injection Pain']}, 'descriptionModule': {'briefSummary': 'Skin infiltration with local anesthetic is commonly used to decrease patient discomfort during peripheral nerve blocks. Topically applied local anesthetic gel might provide analgesia while eliminating the need for additional injections. The primary objective of this study was a noninferiority comparison between the analgesia achieved with topical gel with that of skin infiltration for pain upon needle insertion and injection during administration of the interscalene brachial (ISBP) and axillary (AX) plexus blocks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand Dutch, French or English language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations\n* Age \\>18 at the time of informed consent\n* ASA I-III physical class\n* Scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (ISBP) or axillary (AX) plexus block\n\nExclusion Criteria:\n\n* History of an allergy or contra-indication to a local anesthetic\n* Baseline neurological deficit\n* Medical condition that will make it difficult to assess sensory distribution or communicate with a staff member\n* Presence of preexisting coagulation disorders\n* Infection at injection site\n* Concomitant opioid therapy\n* Recent history (\\<3 months) of drug or alcohol abuse\n* Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at first visit'}, 'identificationModule': {'nctId': 'NCT03206320', 'briefTitle': 'Topical Lidocaine for Needle Insertion and Injection Pain', 'organization': {'class': 'OTHER', 'fullName': 'New York School of Regional Anesthesia'}, 'officialTitle': 'Topical Lidocaine 2% Gel for Analgesia and Patient Comfort During Interscalene Brachial Plexus and Axillary Blocks: A Noninferiority Randomized Trial', 'orgStudyIdInfo': {'id': 'SMBe1701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'interventionNames': ['Drug: Lidocaine Topical']}, {'type': 'EXPERIMENTAL', 'label': 'New', 'interventionNames': ['Drug: Lidocaine Topical']}], 'interventions': [{'name': 'Lidocaine Topical', 'type': 'DRUG', 'description': 'Comparison of lidocaine topical gel with lidocaine infiltration and with no local anesthesia in reducing needle insertion and injection pain', 'armGroupLabels': ['New', 'Reference']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York School of Regional Anesthesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Catherine Vandepitte, M.D.', 'investigatorAffiliation': 'Ziekenhuis Oost-Limburg'}}}}