Pain, Postoperative
Conditions
Keywords
Cesarean section, Postoperative pain
Brief summary
Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.
Detailed description
The purpose of this study is to determine if lidocaine patches decrease post-operative pain associated with cesarean births. While the Lidoderm lidocaine patch has been FDA approved for the treatment of skin pain, it has not been studied in women undergoing cesarean birth who experience postoperative pain. Even though this medication has been used in post-operative pain in published studies, the use of this medicine under these circumstances is still considered experimental. A lidocaine patch may provide added benefit for pain control in addition to standard medicines participants would receive after surgery, such as spinal, intravenous, and oral pain medications following cesarean delivery.
Interventions
Lidocaine patch after cesarean section delivery.
OTHERSham Topical Patch
Sham patch after cesarean section delivery.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant patients who require a scheduled or non-urgent cesarean birth * Patient able to receive neuraxial analgesia * Patient able to give verbal and written consent for both cesarean birth and study
Exclusion criteria
* Patients requiring emergent cesarean birth * Patients allergic to lidocaine or adhesive * Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth * Patients using chronic oral neuromodulators * Patients with cardiac disease or using anti-arrhythmic agents * Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus. * Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-hour Postoperative Pain Scores | 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. |
| 24-hour Postoperative Pain Scores | 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. |
| 36-hour Postoperative Pain Scores | 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. |
| 48-hour Postoperative Pain Scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-days Postoperative Narcotic Use | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Lidoderm 5% Topical Patch | Sham Topical Patch | Total |
|---|---|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 4 | 33.7 years STANDARD_DEVIATION 5.5 | 33.8 years STANDARD_DEVIATION 4.8 |
| BMI | 32.0 kg/m^2 STANDARD_DEVIATION 7.7 | 32.3 kg/m^2 STANDARD_DEVIATION 8.3 | 32.1 kg/m^2 STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 18 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Repeat Cesarean Section | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
12-hour Postoperative Pain Scores
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.
Time frame: Postoperative (12 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidoderm 5% Topical Patch | 12-hour Postoperative Pain Scores | 33.5 score on a scale | Standard Deviation 17 |
| Sham Topical Patch | 12-hour Postoperative Pain Scores | 28.8 score on a scale | Standard Deviation 21.8 |
Primary
24-hour Postoperative Pain Scores
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.
Time frame: Postoperative (24 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidoderm 5% Topical Patch | 24-hour Postoperative Pain Scores | 34.1 score on a scale | Standard Deviation 23.1 |
| Sham Topical Patch | 24-hour Postoperative Pain Scores | 32.9 score on a scale | Standard Deviation 20 |
Primary
36-hour Postoperative Pain Scores
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.
Time frame: Postoperative (36 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidoderm 5% Topical Patch | 36-hour Postoperative Pain Scores | 37.3 score on a scale | Standard Deviation 13.4 |
| Sham Topical Patch | 36-hour Postoperative Pain Scores | 43.0 score on a scale | Standard Deviation 22.8 |
Primary
48-hour Postoperative Pain Scores
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.
Time frame: Postoperative (48 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidoderm 5% Topical Patch | 48-hour Postoperative Pain Scores | 24.8 score on a scale | Standard Deviation 16.1 |
| Sham Topical Patch | 48-hour Postoperative Pain Scores | 29.6 score on a scale | Standard Deviation 23.6 |
Secondary
5-days Postoperative Narcotic Use
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.
Time frame: Postoperative (5 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidoderm 5% Topical Patch | 5-days Postoperative Narcotic Use | 8.6 pills | Standard Deviation 4.4 |
| Sham Topical Patch | 5-days Postoperative Narcotic Use | 8.3 pills | Standard Deviation 5.2 |