Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT04506034
Status:
UNKNOWN
Last Update Posted:
2020-08-10
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, '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': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'randomized controlled trial'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain VAS scores at rest and during coughing were recorded postoperatively', 'timeFrame': '24 hours', 'description': 'To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic surgery in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo.', 'detailedDescription': 'Postoperative pain after gynecologic surgery is a challenging problem associated with increased morbidity and cost. The inflammatory response to surgery plays a crucial rule in inducing postoperative illus. Systemic local anesthetics proved to have anti-inflammatory properties that may be beneficial in preventing ileus added to its analgesic actions. The lidocaine patch evaluated in many types of pain with promising results. The study try to evaluate the patch in perioperative field as a more simple and safe technique than the intravenous route.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female for laparoscopic gynecology', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* female undergoing elective gynecologic surgery\n\nExclusion Criteria:\n\n* known allergy to lidocaine,\n* respiratory or cardiac dysfunction, arrhythmia, treatment with antiarrhythmic drugs,\n* inflammatory bowel disease (Crohn's disease or ulcerative colitis)\n* hepatic, renal\n* chronic use of analgesics or corticosteroids"}, 'identificationModule': {'nctId': 'NCT04506034', 'briefTitle': 'Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Laparoscopic Gynecologic Surgery? A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'aswu/277/7/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lidocaine patches', 'description': 'for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.', 'interventionNames': ['Drug: lidocaine patches']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV lidocaine', 'description': 'received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight \\>70 kg or 1 mg/min if body weight \\<70 kg.', 'interventionNames': ['Drug: IV lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'IV saline infusion', 'description': 'received i.v. saline infusion.', 'interventionNames': ['Drug: IV saline infusion']}], 'interventions': [{'name': 'lidocaine patches', 'type': 'DRUG', 'otherNames': ['lidocaine patch'], 'description': 'for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.', 'armGroupLabels': ['lidocaine patches']}, {'name': 'IV lidocaine', 'type': 'DRUG', 'otherNames': ['lidocaine infusion'], 'description': 'received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight \\>70 kg or 1 mg/min if body weight \\<70 kg.', 'armGroupLabels': ['IV lidocaine']}, {'name': 'IV saline infusion', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'received i.v. saline infusion.', 'armGroupLabels': ['IV saline infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'hany f Sallam, md', 'role': 'CONTACT', 'email': 'hany.farouk@aswu.edu.eg', 'phone': '+20102435461', 'phoneExt': '002'}, {'name': 'nahla w Shady, md', 'role': 'CONTACT', 'email': 'hanygyne@yahoo.com', 'phone': '+201022336052', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'nahla w Shady, md', 'role': 'STUDY_CHAIR', 'affiliation': 'Aswan universirty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A Professor', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}