Trial Outcomes & Findings for The OBstetric Lidocaine Patch (OBLido) Trial (NCT NCT03810235)
NCT ID: NCT03810235
Last Updated: 2025-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
up to 24 hours
Results posted on
2025-08-22
Participant Flow
3 participants delivered prior to randomization, leaving 63 participants to start the trial
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
Participant Data Analyzed
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
The OBstetric Lidocaine Patch (OBLido) Trial
Baseline characteristics by cohort
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 4.9 • n=99 Participants
|
31.1 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
31.83 years
STANDARD_DEVIATION 5.15 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
31 participants
n=107 Participants
|
61 participants
n=206 Participants
|
|
Ethnicity ( NIH/OMB)
Hispanic
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity ( NIH/OMB)
Non- Hispanic
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 24 hoursThe 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.
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Total Dose of Opioids Received in the First 24 Hours Following Cesarean
|
87 MME, morphine milligram equivalents
Standard Deviation 35.8
|
83.9 MME, morphine milligram equivalents
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: up to 24 hoursPopulation: Median Pain Scores Overall and by Prepregancy and Delivery Body Mass Index (BMI)
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.
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Post-operative Pain Score at 24 Hours Post-operatively
Median Pain Score (0-10)
|
3.0 score on a scale
Interval 1.0 to 9.5
|
3.5 score on a scale
Interval 1.0 to 7.0
|
|
Post-operative Pain Score at 24 Hours Post-operatively
Pre pregnancy BMI 30-39.9
|
3.0 score on a scale
Interval 2.0 to 3.2
|
3.0 score on a scale
Interval 2.0 to 5.0
|
|
Post-operative Pain Score at 24 Hours Post-operatively
Prepregancy BMI >40
|
4.0 score on a scale
Interval 2.6 to 4.0
|
4.0 score on a scale
Interval 3.0 to 5.0
|
|
Post-operative Pain Score at 24 Hours Post-operatively
Delivery BMI 30 -39.9
|
3.0 score on a scale
Interval 2.4 to 4.0
|
3.0 score on a scale
Interval 2.0 to 4.5
|
|
Post-operative Pain Score at 24 Hours Post-operatively
Delivery BMI >40
|
3.0 score on a scale
Interval 2.2 to 3.8
|
4.0 score on a scale
Interval 3.0 to 5.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 weeks postpartumPatient-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)
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Number of Participants With Opioid-related Side Effects
|
2 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 weeks postpartumComplications 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)
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Number of Participants With Complications of Lidocaine Use
|
2 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 120 hoursMeasured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Length of Hospital Stay
|
75.5 hours
Interval 70.4 to 96.4
|
76 hours
Interval 71.3 to 91.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24 hoursMeasured 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.
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Time to First Rescue Opioid Analgesic Medication
|
1.4 hours
Interval 0.2 to 4.5
|
1.7 hours
Interval 0.2 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 48 hoursAll 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
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Total Dose of Opioids Used in the First 48 Hours Post-operatively
|
149.3 MME, morphine milligram equivalents
Standard Deviation 58.5
|
139.0 MME, morphine milligram equivalents
Standard Deviation 48.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 120 hoursAll 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.
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Total Dose of Opioids During the Whole Hospitalization.
|
200 MME, morphine milligram equivalents
Interval 0.0 to 448.0
|
192 MME, morphine milligram equivalents
Interval 42.0 to 388.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 120 hoursIncludes 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)
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Number of Participants With Postoperative Complications
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 72 hoursThe number of opioid pills prescribed at discharge
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Number of Opioid Pills Prescribed at Discharge
|
17.3 Number of pills
Standard Deviation 9.0
|
16.0 Number of pills
Standard Deviation 9.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24 hoursGestational age at delivery will be recorded as weeks and days of gestation
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Neonatal Outcomes: Gestational Age at Delivery
|
38.7 weeks
Standard Deviation 1.7
|
38.85 weeks
Standard Deviation 1.85
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 72 hoursDose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge
Outcome measures
| Measure |
Transdermal Lidocaine Patch
n=30 Participants
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 Participants
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.
|
|---|---|---|
|
Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge
|
168.35 MME (mg)
Standard Deviation 120.4
|
154.10 MME (mg)
Standard Deviation 93.9
|
Adverse Events
Transdermal Lidocaine Patch
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Transdermal Hydrocolloid Placebo Patch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transdermal Lidocaine Patch
n=30 participants at risk
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
|
Transdermal Hydrocolloid Placebo Patch
n=31 participants at risk
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
|
|---|---|---|
|
Surgical and medical procedures
Adverse Event ( not serious)
|
3.3%
1/30 • Number of events 1 • 6 weeks post partum
|
0.00%
0/31 • 6 weeks post partum
|
|
Surgical and medical procedures
Adverse Event (not serious)
|
3.3%
1/30 • Number of events 1 • 6 weeks post partum
|
0.00%
0/31 • 6 weeks post partum
|
Additional Information
Kathleen M. Antony, M.D, M.S.C.I
School of Medicine and Public Health University of Wisconsin-Madison
Phone: 608-417-6099
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place