Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT04443569
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2020-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lidocaine Patches After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carkfeld@mgh.harvard.edu', 'phone': '4029803860', 'title': 'Christopher Arkfeld', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'the first 72 hours post-operative', 'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine Patch Group', 'description': 'This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management.\n\nLidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'This group will be women randomized to routine postoperative pain management following cesarean delivery.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Patch Group', 'description': 'This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management.\n\nLidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'This group will be women randomized to routine postoperative pain management following cesarean delivery. A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group.'}], 'classes': [{'title': 'Post-Op Day 1', 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Post-Op Day 2', 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Post-Op Day 3', 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Post-Op Day 4', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Post-Op Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Post-Op Day 2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Post-Op Day 3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Post-Op Day 4', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'the first 72 hours post-operative, up to 4 days', 'description': 'Daily pain scores conducted by the nursing staff every morning and prior to medication administration. This will be a repeated measure using the subjective 0-10 pain scale. The scores will be averaged over each 24 hour (day) period and then compared. Lower scores indicate less pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Narcotic Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Patch Group', 'description': 'This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management.\n\nLidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'This group will be women randomized to routine postoperative pain management following cesarean delivery. A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '53.6', 'groupId': 'OG000'}, {'value': '29.7', 'spread': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'the first 72 hours post-operative', 'description': 'The total average milligrams of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents', 'unitOfMeasure': 'mg morphine equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine Patch Group', 'description': 'This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management.\n\nLidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'This group will be women randomized to routine postoperative pain management following cesarean delivery. A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine Patch Group', 'description': 'This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management.\n\nLidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'This group will be women randomized to routine postoperative pain management following cesarean delivery. A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '33.5', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '33.4', 'spread': '4.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prepregnancy Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '29.6', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '30', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI at Delivery', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '34.5', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '34.9', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gravidity', 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '2', 'groupId': 'BG001'}, {'value': '3.3', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The number of times a woman has been pregnant, regardless of whether the pregnancies were interrupted or resulted in a live birth.', 'unitOfMeasure': 'pregnancies', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parity Term', 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '1.4', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of births a female has had after 20 weeks gestation.', 'unitOfMeasure': 'births', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parity Preterm', 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '0.2', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of births a female has had before 20 weeks gestation.', 'unitOfMeasure': 'births', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parity Abortions', 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '0.9', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '0.9', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of births a female has had resulting in abortions.', 'unitOfMeasure': 'births', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parity Living Children', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '1.6', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '1.5', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of births a female has had resulting in living children.', 'unitOfMeasure': 'births', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational Age at Delivery', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '1', 'groupId': 'BG000'}, {'value': '38.4', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '38.5', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Previous C-sections', 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'c-sections', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-24', 'size': 297604, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-09T14:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessor/statistician will not be made aware of the treatment group of the patients.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a prospective randomized non-blinded controlled trial. All cesarean sections for women undergoing their first or second cesarean delivery will be included. Patients will be approached and consented during the pre-operative period when presenting for scheduled surgery or at the time of consent for a non-scheduled cesarean section. The lidocaine patch would be placed on the superior-lateral aspect of the Pfannenstiel incision in the PACU prior to being transferred to the postpartum floor.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2020-06-19', 'resultsFirstSubmitDate': '2023-08-25', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-21', 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Pain Score', 'timeFrame': 'the first 72 hours post-operative, up to 4 days', 'description': 'Daily pain scores conducted by the nursing staff every morning and prior to medication administration. This will be a repeated measure using the subjective 0-10 pain scale. The scores will be averaged over each 24 hour (day) period and then compared. Lower scores indicate less pain.'}], 'secondaryOutcomes': [{'measure': 'Narcotic Use', 'timeFrame': 'the first 72 hours post-operative', 'description': 'The total average milligrams of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Obstetric Pain', 'Opioid Use']}, 'referencesModule': {'references': [{'pmid': '22715181', 'type': 'BACKGROUND', 'citation': "Gilhooly D, McGarvey B, O'Mahony H, O'Connor TC. Topical lidocaine patch 5% for acute postoperative pain control. BMJ Case Rep. 2011 Feb 8;2011:bcr0620103074. doi: 10.1136/bcr.06.2010.3074."}, {'pmid': '22861076', 'type': 'BACKGROUND', 'citation': 'Kwon YS, Kim JB, Jung HJ, Koo YJ, Lee IH, Im KT, Woo JS, Im KS. Treatment for postoperative wound pain in gynecologic laparoscopic surgery: topical lidocaine patches. J Laparoendosc Adv Surg Tech A. 2012 Sep;22(7):668-73. doi: 10.1089/lap.2011.0440. Epub 2012 Aug 3.'}], 'seeAlsoLinks': [{'url': 'https://casereports.bmj.com/content/2011/bcr.06.2010.3074', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the impact of using lidocaine patches after cesarean section on pain control and opioid use in the immediate post-operative period. The hypothesis is the use of lidocaine patches in the immediate post-operative period will lead to a decrease in the visual analog pain score compared to women who do not use a lidocaine patch in the immediate post-operative period following cesarean delivery. Additionally, a decrease in the use of opioids as pain control compared to patients that do not have a lidocaine patch in place the is anticipated.', 'detailedDescription': "The use of lidocaine as a local anesthetic is a common and widely used in practice. Lidocaine patches can be used for localized pain control and can be placed every 24 hours. The use of lidocaine patches in post-operative patients has been reported in one case report in obstetric literature. There is one study that reports decreased immediate postoperative pain when lidocaine patches were placed at laparoscopic port sites following gynecologic surgery as measured by visual analog scale score and the Prince Henry and 5-point verbal rating pain scale. There have been no studies looking at the impact of lidocaine patches in obstetric surgical procedures, specifically cesarean sections.\n\nCesarean sections are one of the most common surgeries in the United States. Following cesarean sections it is common to utilize opioids in the hospital and upon discharge to manage patient's post-operative pain. According to the CDC overdose deaths involving prescription opioids were five times higher in 2017 than in 1999 with over 200,000 deaths. This creates an opportunity to decrease the use of post-operative opioids with the application of a lidocaine patch as an adjunctive post-operative pain management modality following cesarean sections.\n\nLidocaine patches are a common topical analgesia therapy used for localized pain control in the inpatient and outpatient setting. It's use in the postoperative period is less understood and the use of topical lidocaine patches has not been thoroughly investigated in the surgical literature. Thus far, it has been shown as an effective therapy at laparoscopic port sites following laparoscopic appendectomies. It's use in obstetrical surgeries has not been studied. Overall, the limited research on this topic making it a valuable area of research.\n\nThis study will involve prospective enrollment of women undergoing cesarean deliveries. Women will be randomized to receive a lidocaine patch or no lidocaine patch to be worn for 72 hours after delivery to help manage postoperative pain. This will be an adjunctive therapy in addition to the parental and oral narcotic pain medication that is routine prescribed. The utility of lidocaine patches for management of post-cesarean delivery pain will be assess by 2 measures. The first measure will involve the total daily dose of narcotic used in morphine equivalent doses. The second outcome assessed will be subjective pain as measured on a 1-10 scale and reported by the patients to nursing staff. This score will be averaged for each 24 hour period post-operatively."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients need to be pregnant and undergoing a cesarean delivery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Primary or secondary cesarean delivery\n* Able to consent to research study\n\nExclusion Criteria:\n\n* 3 or more prior cesarean deliveries\n* History of abdominoplasty\n* History of abdominal hernia repair with mesh\n* Allergy to lidocaine\n* Allergy to adhesives in medical tape\n* Women who received general anesthesia for their cesarean delivery\n* Women with active substance abuse\n* Women methadone or suboxone for a history of opiate abuse'}, 'identificationModule': {'nctId': 'NCT04443569', 'acronym': 'LPACS', 'briefTitle': 'Lidocaine Patches After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Lidocaine Patches After Cesarean Section', 'orgStudyIdInfo': {'id': '2000028500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine Patch Group', 'description': 'This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management.', 'interventionNames': ['Drug: Lidocaine patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'This group will be women randomized to routine postoperative pain management following cesarean delivery. A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group.', 'interventionNames': ['Other: Placebo patch']}], 'interventions': [{'name': 'Lidocaine patch', 'type': 'DRUG', 'description': 'Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management', 'armGroupLabels': ['Lidocaine Patch Group']}, {'name': 'Placebo patch', 'type': 'OTHER', 'description': 'A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06512', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Audrey Merriam, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences'}, {'name': 'Christopher Arkfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}