Trial Outcomes & Findings for Lidocaine Patches After Cesarean Section (NCT NCT04443569)
NCT ID: NCT04443569
Last Updated: 2024-11-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
93 participants
Primary outcome timeframe
the first 72 hours post-operative, up to 4 days
Results posted on
2024-11-06
Participant Flow
Participant milestones
| Measure |
Lidocaine Patch Group
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.
Lidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
|
Control Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
|
Overall Study
COMPLETED
|
46
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lidocaine Patches After Cesarean Section
Baseline characteristics by cohort
| Measure |
Lidocaine Patch Group
n=46 Participants
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.
Lidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
|
Control Group
n=47 Participants
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.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 3.9 • n=99 Participants
|
33.5 years
STANDARD_DEVIATION 4.6 • n=107 Participants
|
33.4 years
STANDARD_DEVIATION 4.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 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
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
60 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
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=99 Participants
|
47 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
Prepregnancy Body Mass Index (BMI)
|
30.4 kg/m^2
STANDARD_DEVIATION 7.8 • n=99 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 6.6 • n=107 Participants
|
30 kg/m^2
STANDARD_DEVIATION 7.2 • n=206 Participants
|
|
BMI at Delivery
|
35.3 kg/m^2
STANDARD_DEVIATION 6.9 • n=99 Participants
|
34.5 kg/m^2
STANDARD_DEVIATION 6.7 • n=107 Participants
|
34.9 kg/m^2
STANDARD_DEVIATION 6.8 • n=206 Participants
|
|
Gravidity
|
3.2 pregnancies
STANDARD_DEVIATION 1.6 • n=99 Participants
|
3.4 pregnancies
STANDARD_DEVIATION 2 • n=107 Participants
|
3.3 pregnancies
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
Parity Term
|
1.3 births
STANDARD_DEVIATION 0.8 • n=99 Participants
|
1.5 births
STANDARD_DEVIATION 0.9 • n=107 Participants
|
1.4 births
STANDARD_DEVIATION 0.8 • n=206 Participants
|
|
Parity Preterm
|
0.2 births
STANDARD_DEVIATION 1.3 • n=99 Participants
|
0.1 births
STANDARD_DEVIATION 0.3 • n=107 Participants
|
0.2 births
STANDARD_DEVIATION 1.0 • n=206 Participants
|
|
Parity Abortions
|
0.9 births
STANDARD_DEVIATION 1.5 • n=99 Participants
|
0.9 births
STANDARD_DEVIATION 1.2 • n=107 Participants
|
0.9 births
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Parity Living Children
|
1.4 births
STANDARD_DEVIATION 0.9 • n=99 Participants
|
1.6 births
STANDARD_DEVIATION 0.9 • n=107 Participants
|
1.5 births
STANDARD_DEVIATION 0.9 • n=206 Participants
|
|
Gestational Age at Delivery
|
38.6 weeks
STANDARD_DEVIATION 1 • n=99 Participants
|
38.4 weeks
STANDARD_DEVIATION 1.3 • n=107 Participants
|
38.5 weeks
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
Number of Previous C-sections
|
1 c-sections
STANDARD_DEVIATION 0.7 • n=99 Participants
|
1.1 c-sections
STANDARD_DEVIATION 0.7 • n=107 Participants
|
1.1 c-sections
STANDARD_DEVIATION 0.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: the first 72 hours post-operative, up to 4 daysDaily 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.
Outcome measures
| Measure |
Lidocaine Patch Group
n=46 Participants
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.
Lidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
|
Control Group
n=47 Participants
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.
|
|---|---|---|
|
Visual Analog Pain Score
Post-Op Day 1
|
3.5 score on a scale
Standard Deviation 2.3
|
4.1 score on a scale
Standard Deviation 2.5
|
|
Visual Analog Pain Score
Post-Op Day 2
|
5.2 score on a scale
Standard Deviation 2.6
|
5.2 score on a scale
Standard Deviation 2
|
|
Visual Analog Pain Score
Post-Op Day 3
|
5.2 score on a scale
Standard Deviation 2.1
|
4.3 score on a scale
Standard Deviation 1.7
|
|
Visual Analog Pain Score
Post-Op Day 4
|
5.7 score on a scale
Standard Deviation 1.9
|
4.5 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: the first 72 hours post-operativeThe total average milligrams of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents
Outcome measures
| Measure |
Lidocaine Patch Group
n=46 Participants
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.
Lidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
|
Control Group
n=47 Participants
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.
|
|---|---|---|
|
Narcotic Use
|
51.3 mg morphine equivalents
Standard Deviation 53.6
|
29.7 mg morphine equivalents
Standard Deviation 35
|
Adverse Events
Lidocaine Patch Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place