Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-29 @ 4:50 AM
Study NCT ID:
NCT03810235
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The OBstetric Lidocaine Patch (OBLido) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047070', 'term': 'Bandages, Hydrocolloid'}], 'ancestors': [{'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kantony@wisc.edu', 'phone': '608-417-6099', 'title': 'Kathleen M. Antony, M.D, M.S.C.I', 'organization': 'School of Medicine and Public Health University of Wisconsin-Madison'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks post partum', 'eventGroups': [{'id': 'EG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Adverse Event ( not serious)', 'notes': 'Seen in ER after initial hospital discharge for abdominal pain: resolved spontaneously.\n\nOutcome: Recovered without sequelae Severity: Mild SAE Category: "Other" AE Treatment: None Action taken: None Attribution: Relatedness: Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Event (not serious)', 'notes': 'Delayed postpartum hemorrhage 6 weeks postpartum requiring D\\&C Outcome: Recovered without sequelae Severity: Moderate SAE Category: Other AE Treatment: Non-mediation treatment Action taken with study: None Attribution/ relatedness: Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Dose of Opioids Received in the First 24 Hours Following Cesarean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'spread': '35.8', 'groupId': 'OG000'}, {'value': '83.9', 'spread': '27.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours', 'description': 'The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.', 'unitOfMeasure': 'MME, morphine milligram equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-operative Pain Score at 24 Hours Post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches'}], 'classes': [{'title': 'Median Pain Score (0-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '9.5'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Pre pregnancy BMI 30-39.9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.2'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '5.0'}]}]}, {'title': 'Prepregancy BMI >40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '4.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.0'}]}]}, {'title': 'Delivery BMI 30 -39.9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.5'}]}]}, {'title': 'Delivery BMI >40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '3.8'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 24 hours', 'description': 'The post-operative pain score at 24 hours post-operatively will be measured using the numeric rating scale (NRS), wherein subjects rate pain on a 0-10 scale (10 meaning the most pain and 0 meaning no pain). The median NRS score at 24 hours will be compared between the two groups.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Median Pain Scores Overall and by Prepregancy and Delivery Body Mass Index (BMI)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Opioid-related Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Patient-reported opioid-related side effects include pruritis, constipation, nausea, and mental clouding.\n\nDefinition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Complications of Lidocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.\n\nDefinition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '70.4', 'upperLimit': '96.4'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '71.3', 'upperLimit': '91.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 120 hours', 'description': 'Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to First Rescue Opioid Analgesic Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.5'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 24 hours', 'description': 'Measured in minutes from arrival in the post-anesthesia care unit (PACU) until the first as needed opioid dose is administered. This will be recorded in minutes from the time of the surgery completion (surgery end time) until the first opioid analgesic medication is administered. Data in table is noted in hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Dose of Opioids Used in the First 48 Hours Post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches'}], 'classes': [{'categories': [{'measurements': [{'value': '149.3', 'spread': '58.5', 'groupId': 'OG000'}, {'value': '139.0', 'spread': '48.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 48 hours', 'description': 'All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received in 48 hours following surgery calculated as oral morphine equivalents', 'unitOfMeasure': 'MME, morphine milligram equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Dose of Opioids During the Whole Hospitalization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '448'}, {'value': '192', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '388'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 120 hours', 'description': 'All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received during the hospitalization (following surgery) calculated as oral morphine equivalents.', 'unitOfMeasure': 'MME, morphine milligram equivalents', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 120 hours', 'description': 'Includes urinary tract infections, thromboembolic events, pneumonia, postpartum blood transfusions, falls, myocardial infarctions.\n\nThese events will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Opioid Pills Prescribed at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '9.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 72 hours', 'description': 'The number of opioid pills prescribed at discharge', 'unitOfMeasure': 'Number of pills', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neonatal Outcomes: Gestational Age at Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '38.85', 'spread': '1.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours', 'description': 'Gestational age at delivery will be recorded as weeks and days of gestation', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'OG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.'}], 'classes': [{'categories': [{'measurements': [{'value': '168.35', 'spread': '120.4', 'groupId': 'OG000'}, {'value': '154.10', 'spread': '93.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 72 hours', 'description': 'Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge', 'unitOfMeasure': 'MME (mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'FG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Participant Data Analyzed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '3 participants delivered prior to randomization, leaving 63 participants to start the trial'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Lidocaine Patch: Transdermal Lidocaine Patch'}, {'id': 'BG001', 'title': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.\n\nTransdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '31.1', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '31.83', 'spread': '5.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', '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': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity ( NIH/OMB)', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Non- Hispanic', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'baseline characteristics for participants who completed the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-08', 'size': 6456414, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-09T13:37', 'hasProtocol': True}, {'date': '2019-02-13', 'size': 342241, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-11-21T11:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'single-center, single blind, randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2019-01-07', 'resultsFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2019-01-16', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-19', 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Opioid-related Side Effects', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Patient-reported opioid-related side effects include pruritis, constipation, nausea, and mental clouding.\n\nDefinition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)'}, {'measure': 'Number of Participants With Complications of Lidocaine Use', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.\n\nDefinition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'up to 120 hours', 'description': 'Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge'}, {'measure': 'Time to First Rescue Opioid Analgesic Medication', 'timeFrame': 'up to 24 hours', 'description': 'Measured in minutes from arrival in the post-anesthesia care unit (PACU) until the first as needed opioid dose is administered. This will be recorded in minutes from the time of the surgery completion (surgery end time) until the first opioid analgesic medication is administered. Data in table is noted in hours.'}, {'measure': 'Total Dose of Opioids Used in the First 48 Hours Post-operatively', 'timeFrame': 'up to 48 hours', 'description': 'All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received in 48 hours following surgery calculated as oral morphine equivalents'}, {'measure': 'Total Dose of Opioids During the Whole Hospitalization.', 'timeFrame': 'up to 120 hours', 'description': 'All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received during the hospitalization (following surgery) calculated as oral morphine equivalents.'}, {'measure': 'Number of Participants With Postoperative Complications', 'timeFrame': 'up to 120 hours', 'description': 'Includes urinary tract infections, thromboembolic events, pneumonia, postpartum blood transfusions, falls, myocardial infarctions.\n\nThese events will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)'}, {'measure': 'Number of Opioid Pills Prescribed at Discharge', 'timeFrame': 'up to 72 hours', 'description': 'The number of opioid pills prescribed at discharge'}, {'measure': 'Neonatal Outcomes: Gestational Age at Delivery', 'timeFrame': 'up to 24 hours', 'description': 'Gestational age at delivery will be recorded as weeks and days of gestation'}, {'measure': 'Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge', 'timeFrame': 'up to 72 hours', 'description': 'Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge'}], 'primaryOutcomes': [{'measure': 'Total Dose of Opioids Received in the First 24 Hours Following Cesarean', 'timeFrame': 'up to 24 hours', 'description': 'The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.'}], 'secondaryOutcomes': [{'measure': 'Post-operative Pain Score at 24 Hours Post-operatively', 'timeFrame': 'up to 24 hours', 'description': 'The post-operative pain score at 24 hours post-operatively will be measured using the numeric rating scale (NRS), wherein subjects rate pain on a 0-10 scale (10 meaning the most pain and 0 meaning no pain). The median NRS score at 24 hours will be compared between the two groups.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lidocaine', 'patch'], 'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '33451596', 'type': 'DERIVED', 'citation': 'Antony KM, Adams JH, Jacques L, Hetzel S, Chappell RJ, Gnadt SE, Tevaarwerk AJ. Lidocaine patches for postcesarean pain control in obese women: a pilot randomized controlled trial. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100281. doi: 10.1016/j.ajogmf.2020.100281. Epub 2020 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'This study will be a single-center, single blind, randomized controlled trial. The study will be conducted at UnityPoint-Health Meriter Hospital under investigators from the University of Wisconsin-Madison. Obstetric patients with prepregnancy obesity undergoing a Cesarean delivery at UnityPoint-Health Meriter will be eligible.', 'detailedDescription': 'The purpose of this study is to determine whether transdermal lidocaine administered at the time of Cesarean delivery and for 12 hours postoperatively will reduce the total dose of opioids received. Our hypothesis is that a lidocaine patch will reduce the total dose of opioids received in the immediate 24 hours post-delivery. Secondary outcomes will include patient self-reported pain scores, patient-reported incidence of side effects, such as pruritis, development of objective complications, such as serious skin reactions (examples are acute generalized exanthematous pustolosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis), hypersensitivity, nausea, and nervousness. Other outcomes collected will include length of stay, time to first rescue analgesic medication, total dose of opioids in 48 hours, use of supplemental oxygen during hospitalization, total dose of opioids during hospitalization, breastfeeding rates, both exclusive and in combination with formula use, amount of opioid prescribed at discharge and whether refills were requested or administered, rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen scores. Neonatal outcomes such as five-minute Apgar scores and development of adverse outcomes will also be collected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maternal age greater than or equal to 18\n* Prepregnancy body mass index greater than or equal to 30 kg/m2 or ≥35 kg/m2 at delivery if no prepregnancy/ early pregnancy weight available\n* Singleton or multifetal pregnancy\n* Able to receive neuraxial analgesia\n* Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery with adequate time to consider and consent to the study\n* Gestational age greater or equal to 32 weeks\n\nExclusion Criteria:\n\n* Known hypersensitivity to lidocaine or colloid patch (defined as a history of a reaction or allergy to lidocaine (injectable, intravenous, or transdermal) or hydrocolloid patch reported by patient or documented in the medical record) or patient report\n* Contraindication to regional analgesia\n* Positive urine drug screen at admission to the hospital, if ordered for clinical purposes.\n* Current opioid use or opioid use disorder per patient report or documented in the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery)\n* Chronic opioid use or opioid use disorder, either patient reported or documented in the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery), defined as opioid use on most days for \\>3 months\n* Planned Cesarean hysterectomy (excluded due to anticipated blood loss and alternative pain control measures, possible prolonged intubation)\n* Planned vertical midline incision\n* Presence of renal dysfunction precluding the use of NSAIDs\n* Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy\n* Coagulopathy\n* Planned discharge from the hospital less than 24 hours postpartum'}, 'identificationModule': {'nctId': 'NCT03810235', 'acronym': 'OBLido', 'briefTitle': 'The OBstetric Lidocaine Patch (OBLido) Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Transdermal Lidocaine Patch for Post-Cesarean Pain Control for Women With Obesity: a Single-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Meriter IRB 2018-015'}, 'secondaryIdInfos': [{'id': 'A532860', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/OBSTET & GYNECOL/OBSTET', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '2019-0139', 'type': 'OTHER', 'domain': 'UW-Madison IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transdermal Lidocaine Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.', 'interventionNames': ['Drug: Transdermal Lidocaine Patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Transdermal Hydrocolloid Placebo Patch', 'description': 'Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.', 'interventionNames': ['Drug: Transdermal Hydrocolloid Placebo Patch']}], 'interventions': [{'name': 'Transdermal Lidocaine Patch', 'type': 'DRUG', 'otherNames': ['Actavis US', 'NDC 0591-3525-30'], 'description': 'Transdermal Lidocaine Patch', 'armGroupLabels': ['Transdermal Lidocaine Patch']}, {'name': 'Transdermal Hydrocolloid Placebo Patch', 'type': 'DRUG', 'otherNames': ['DuoDerm', 'ConvaTec'], 'description': 'hydrocolloid placebo patches', 'armGroupLabels': ['Transdermal Hydrocolloid Placebo Patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UnityPoint Health-Meriter Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Kathleen Antony, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW-Madison Obstetrics and Gynecology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}