Trial Outcomes & Findings for Post-Op Lidocaine Patch (NCT NCT03500211)
NCT ID: NCT03500211
Last Updated: 2020-03-11
Results Overview
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 12 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
COMPLETED
PHASE4
50 participants
Postoperative (12 hours)
2020-03-11
Participant Flow
Participant milestones
| Measure |
Lidoderm 5% Topical Patch
5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery.
|
Sham Topical Patch
Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Sham Topical Patch: Sham patch after cesarean section delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Lidoderm 5% Topical Patch
5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery.
|
Sham Topical Patch
Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Sham Topical Patch: Sham patch after cesarean section delivery.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Post-Op Lidocaine Patch
Baseline characteristics by cohort
| Measure |
Lidoderm 5% Topical Patch
n=25 Participants
5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery.
|
Sham Topical Patch
n=25 Participants
Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Sham Topical Patch: Sham patch after cesarean section delivery.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 4.0 • n=99 Participants
|
33.7 years
STANDARD_DEVIATION 5.5 • n=107 Participants
|
33.8 years
STANDARD_DEVIATION 4.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 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
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
BMI
|
32.0 kg/m^2
STANDARD_DEVIATION 7.7 • n=99 Participants
|
32.3 kg/m^2
STANDARD_DEVIATION 8.3 • n=107 Participants
|
32.1 kg/m^2
STANDARD_DEVIATION 7.9 • n=206 Participants
|
|
Repeat Cesarean Section
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Postoperative (12 hours)To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 12 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Outcome measures
| Measure |
Lidoderm 5% Topical Patch
n=25 Participants
5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery.
|
Sham Topical Patch
n=25 Participants
Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Sham Topical Patch: Sham patch after cesarean section delivery.
|
|---|---|---|
|
12-hour Postoperative Pain Scores
|
33.5 score on a scale
Standard Deviation 17.0
|
28.8 score on a scale
Standard Deviation 21.8
|
PRIMARY outcome
Timeframe: Postoperative (24 hours)To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Outcome measures
| Measure |
Lidoderm 5% Topical Patch
n=25 Participants
5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery.
|
Sham Topical Patch
n=25 Participants
Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Sham Topical Patch: Sham patch after cesarean section delivery.
|
|---|---|---|
|
24-hour Postoperative Pain Scores
|
34.1 score on a scale
Standard Deviation 23.1
|
32.9 score on a scale
Standard Deviation 20.0
|
PRIMARY outcome
Timeframe: Postoperative (36 hours)To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 36 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Outcome measures
| Measure |
Lidoderm 5% Topical Patch
n=24 Participants
5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery.
|
Sham Topical Patch
n=24 Participants
Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Sham Topical Patch: Sham patch after cesarean section delivery.
|
|---|---|---|
|
36-hour Postoperative Pain Scores
|
37.3 score on a scale
Standard Deviation 13.4
|
43.0 score on a scale
Standard Deviation 22.8
|
PRIMARY outcome
Timeframe: Postoperative (48 hours)To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 48 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Outcome measures
| Measure |
Lidoderm 5% Topical Patch
n=24 Participants
5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery.
|
Sham Topical Patch
n=24 Participants
Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Sham Topical Patch: Sham patch after cesarean section delivery.
|
|---|---|---|
|
48-hour Postoperative Pain Scores
|
24.8 score on a scale
Standard Deviation 16.1
|
29.6 score on a scale
Standard Deviation 23.6
|
SECONDARY outcome
Timeframe: Postoperative (5 days)To determine if narcotic use changes when patients use lidocaine patches by counting amount and frequency of narcotic use over admission. Average number of 5 mg oxycodone pills used in women who have undergone cesarean delivery assessed through questionnaire at 5 days postoperatively.
Outcome measures
| Measure |
Lidoderm 5% Topical Patch
n=24 Participants
5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Lidoderm 5 % Topical Patch: Lidocaine patch after cesarean section delivery.
|
Sham Topical Patch
n=25 Participants
Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Sham Topical Patch: Sham patch after cesarean section delivery.
|
|---|---|---|
|
5-days Postoperative Narcotic Use
|
8.6 pills
Standard Deviation 4.4
|
8.3 pills
Standard Deviation 5.2
|
Adverse Events
Lidoderm 5% Topical Patch
Sham Topical Patch
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
OB/Gyn Regulatory Specialist
Oregon Health & Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place