Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT04754451
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2021-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Lidocaine Patch for Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The pain score', 'timeFrame': '24 hours after the anesthesia finished.', 'description': 'VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain'}], 'secondaryOutcomes': [{'measure': 'The pain score', 'timeFrame': '30 min after the anesthesia finished.', 'description': 'VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain'}, {'measure': 'The pain score', 'timeFrame': '2 hours after the anesthesia finished.', 'description': 'VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain'}, {'measure': 'Total amount of cumulative analgesics', 'timeFrame': '24 hours after the anesthesia finished.', 'description': 'total amount of analgesics are measured for 24 hours after surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'referencesModule': {'references': [{'pmid': '36089597', 'type': 'DERIVED', 'citation': 'Ahn HM, Oh HK, Kim DW, Kang SB, Koo BW, Lee PB. Efficacy and safety of 5% lidocaine patches for postoperative pain management in patients undergoing unilateral inguinal hernia repair: study protocol for a prospective, double-blind, randomized, controlled clinical trial. Trials. 2022 Sep 11;23(1):767. doi: 10.1186/s13063-022-06700-3.'}]}, 'descriptionModule': {'briefSummary': 'The lidocaine patch is currently only permitted for post herpetic neuralgia but the investigators want to study its effectiveness in post operative pain after inguinal herniorrhaphy', 'detailedDescription': 'After open unilateral inguinal herniorrhaphy, patients are randomly divided into group L and group P groups. Group L attaches two lidocaine patches for 12 hours, above and below the incision site. Group P attaches two placebo patches for 12 hours, above and below the incision site. Pain scores are recorded for 30 minutes, 2 hours, 24 hours, and 1 week after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status I - II\n* Scheduled open unilateral herniorrhaphy\n\nExclusion Criteria:\n\n* body mass index (BMI) \\< 18.5 or ≥ 35 kg/m2\n* severe renal or hepatic dysfunction\n* allergy to amide-based local anesthetic agents\n* taking class 1 antiarrhythmic drugs (tocainide and mexiletine, etc.)'}, 'identificationModule': {'nctId': 'NCT04754451', 'briefTitle': 'The Effect of Lidocaine Patch for Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'The Efficacy and Safety of 5% Lidocaine Patch for Postoperative Pain in Unilateral Inguinal Herniorrhaphy', 'orgStudyIdInfo': {'id': 'LDPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group P(placebo)', 'description': 'Attach two placebo patches for 12 hours, above and below the incision site.'}, {'type': 'EXPERIMENTAL', 'label': 'Group L(lidocaine patch)', 'description': 'Attach two lidocaine patches for 12 hours, above and below the incision site.', 'interventionNames': ['Drug: Group L']}], 'interventions': [{'name': 'Group L', 'type': 'DRUG', 'otherNames': ['lidotopcaplasma'], 'description': 'Attach two lidocaine patches for 12 hours, one above and below the incision site.', 'armGroupLabels': ['Group L(lidocaine patch)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Gyonggido', 'country': 'South Korea', 'facility': 'Seoul National Universuty, Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'BON WOOK KOO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BON WOOK KOO', 'class': 'OTHER'}, 'collaborators': [{'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'associative professor of anesthesiology', 'investigatorFullName': 'BON WOOK KOO', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}