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| ID | Type | Description | Link |
|---|---|---|---|
| A532860 | Other Identifier | UW Madison | |
| SMPH/OBSTET & GYNECOL/OBSTET | Other Identifier | UW Madison | |
| 2019-0139 | Other Identifier | UW-Madison IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdermal Lidocaine Patch | Active Comparator | Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery. |
|
| Transdermal Hydrocolloid Placebo Patch | Placebo Comparator | Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal Lidocaine Patch | Drug | Transdermal Lidocaine Patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Dose of Opioids Received in the First 24 Hours Following Cesarean | 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. | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Score at 24 Hours Post-operatively | 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. | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Opioid-related Side Effects | Patient-reported opioid-related side effects include pruritis, constipation, nausea, and mental clouding. Definition: 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) | up to 6 weeks postpartum |
Inclusion Criteria:
Exclusion Criteria:
pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Antony, MD | UW-Madison Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UnityPoint Health-Meriter Hospital | Madison | Wisconsin | 53715 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33451596 | Derived | 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. |
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3 participants delivered prior to randomization, leaving 63 participants to start the trial
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| ID | Title | Description |
|---|---|---|
| FG000 | Transdermal Lidocaine Patch | Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery. Transdermal Lidocaine Patch: Transdermal Lidocaine Patch |
| FG001 | Transdermal Hydrocolloid Placebo Patch | Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery. Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
baseline characteristics for participants who completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Transdermal Lidocaine Patch | Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery. Transdermal Lidocaine Patch: Transdermal Lidocaine Patch |
| BG001 | Transdermal Hydrocolloid Placebo Patch |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Dose of Opioids Received in the First 24 Hours Following Cesarean | 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. | Posted | Mean | Standard Deviation | MME, morphine milligram equivalents | up to 24 hours |
|
6 weeks post partum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transdermal Lidocaine Patch | Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery. Transdermal Lidocaine Patch: Transdermal Lidocaine Patch |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Event ( not serious) | Surgical and medical procedures | Systematic Assessment | Seen in ER after initial hospital discharge for abdominal pain: resolved spontaneously. Outcome: Recovered without sequelae Severity: Mild SAE Category: "Other" AE Treatment: None Action taken: None Attribution: Relatedness: Unrelated |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen M. Antony, M.D, M.S.C.I | School of Medicine and Public Health University of Wisconsin-Madison | 608-417-6099 | kantony@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2019 | Jul 9, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 13, 2019 | Nov 21, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D047070 | Bandages, Hydrocolloid |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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single-center, single blind, randomized controlled trial
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| Transdermal Hydrocolloid Placebo Patch | Drug | hydrocolloid placebo patches |
|
|
| Number of Participants With Complications of Lidocaine Use | 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. Definition: 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) | up to 6 weeks postpartum |
| Length of Hospital Stay | Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge | up to 120 hours |
| Time to First Rescue Opioid Analgesic Medication | 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. | up to 24 hours |
| Total Dose of Opioids Used in the First 48 Hours Post-operatively | 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 | up to 48 hours |
| Total Dose of Opioids During the Whole Hospitalization. | 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. | up to 120 hours |
| Number of Participants With Postoperative Complications | Includes urinary tract infections, thromboembolic events, pneumonia, postpartum blood transfusions, falls, myocardial infarctions. These events will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect) | up to 120 hours |
| Number of Opioid Pills Prescribed at Discharge | The number of opioid pills prescribed at discharge | up to 72 hours |
| Neonatal Outcomes: Gestational Age at Delivery | Gestational age at delivery will be recorded as weeks and days of gestation | up to 24 hours |
| Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge | Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge | up to 72 hours |
Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery. Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Ethnicity ( NIH/OMB) | Count of Participants | Participants |
|
| Transdermal Hydrocolloid Placebo Patch |
Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery. Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches. |
|
|
| Secondary | Post-operative Pain Score at 24 Hours Post-operatively | 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. | Median Pain Scores Overall and by Prepregancy and Delivery Body Mass Index (BMI) | Posted | Median | Inter-Quartile Range | score on a scale | up to 24 hours |
|
|
|
| Other Pre-specified | Number of Participants With Opioid-related Side Effects | Patient-reported opioid-related side effects include pruritis, constipation, nausea, and mental clouding. Definition: 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) | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
|
|
| Other Pre-specified | Number of Participants With Complications of Lidocaine Use | 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. Definition: 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) | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
|
|
| Other Pre-specified | Length of Hospital Stay | Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge | Posted | Median | Inter-Quartile Range | hours | up to 120 hours |
|
|
|
| Other Pre-specified | Time to First Rescue Opioid Analgesic Medication | 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. | Posted | Median | Full Range | hours | up to 24 hours |
|
|
|
| Other Pre-specified | Total Dose of Opioids Used in the First 48 Hours Post-operatively | 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 | Posted | Mean | Standard Deviation | MME, morphine milligram equivalents | up to 48 hours |
|
|
|
| Other Pre-specified | Total Dose of Opioids During the Whole Hospitalization. | 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. | Posted | Median | Full Range | MME, morphine milligram equivalents | up to 120 hours |
|
|
|
| Other Pre-specified | Number of Participants With Postoperative Complications | Includes urinary tract infections, thromboembolic events, pneumonia, postpartum blood transfusions, falls, myocardial infarctions. These events will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect) | Posted | Count of Participants | Participants | up to 120 hours |
|
|
|
| Other Pre-specified | Number of Opioid Pills Prescribed at Discharge | The number of opioid pills prescribed at discharge | Posted | Mean | Standard Deviation | Number of pills | up to 72 hours |
|
|
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| Other Pre-specified | Neonatal Outcomes: Gestational Age at Delivery | Gestational age at delivery will be recorded as weeks and days of gestation | Posted | Mean | Standard Deviation | weeks | up to 24 hours |
|
|
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| Other Pre-specified | Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge | Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge | Posted | Mean | Standard Deviation | MME (mg) | up to 72 hours |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Transdermal Hydrocolloid Placebo Patch | Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery. Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches | 0 | 31 | 0 | 31 | 0 | 31 |
|
| Adverse Event (not serious) | Surgical and medical procedures | Systematic Assessment | 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 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Pre pregnancy BMI 30-39.9 |
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| Prepregancy BMI >40 |
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| Delivery BMI 30 -39.9 |
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| Delivery BMI >40 |
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