Pain, Postoperative
Conditions
Keywords
lidocaine, patch
Brief summary
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.
Detailed description
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.
Interventions
DRUGTransdermal Lidocaine Patch
Transdermal Lidocaine Patch
DRUGTransdermal Hydrocolloid Placebo Patch
hydrocolloid placebo patches
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
single-center, single blind, randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Maternal age greater than or equal to 18 * Prepregnancy body mass index greater than or equal to 30 kg/m2 or ≥35 kg/m2 at delivery if no prepregnancy/ early pregnancy weight available * Singleton or multifetal pregnancy * Able to receive neuraxial analgesia * Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery with adequate time to consider and consent to the study * Gestational age greater or equal to 32 weeks
Exclusion criteria
* Known hypersensitivity to lidocaine or colloid patch (defined as a history of a reaction or allergy to lidocaine (injectable, intravenous, or transdermal) or hydrocolloid patch reported by patient or documented in the medical record) or patient report * Contraindication to regional analgesia * Positive urine drug screen at admission to the hospital, if ordered for clinical purposes. * Current opioid use or opioid use disorder per patient report or documented in the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery) * Chronic opioid use or opioid use disorder, either patient reported or documented in the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery), defined as opioid use on most days for \>3 months * Planned Cesarean hysterectomy (excluded due to anticipated blood loss and alternative pain control measures, possible prolonged intubation) * Planned vertical midline incision * Presence of renal dysfunction precluding the use of NSAIDs * Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy * Coagulopathy * Planned discharge from the hospital less than 24 hours postpartum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Dose of Opioids Received in the First 24 Hours Following Cesarean | up to 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Score at 24 Hours Post-operatively | up to 24 hours | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | up to 120 hours | Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge |
| Time to First Rescue Opioid Analgesic Medication | up to 24 hours | 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. |
| Total Dose of Opioids Used in the First 48 Hours Post-operatively | up to 48 hours | 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 |
| Total Dose of Opioids During the Whole Hospitalization. | up to 120 hours | 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. |
| Number of Participants With Opioid-related Side Effects | up to 6 weeks postpartum | 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) |
| Number of Opioid Pills Prescribed at Discharge | up to 72 hours | The number of opioid pills prescribed at discharge |
| Neonatal Outcomes: Gestational Age at Delivery | up to 24 hours | Gestational age at delivery will be recorded as weeks and days of gestation |
| Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge | up to 72 hours | Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge |
| Number of Participants With Postoperative Complications | up to 120 hours | 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) |
| Number of Participants With Complications of Lidocaine Use | up to 6 weeks postpartum | 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) |
Countries
United States
Participant flow
Pre-assignment details
3 participants delivered prior to randomization, leaving 63 participants to start the trial
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 31 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Transdermal Lidocaine Patch | Total | Transdermal Hydrocolloid Placebo Patch |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 61 Participants | 31 Participants |
| Age, Continuous | 32.6 years STANDARD_DEVIATION 4.9 | 31.83 years STANDARD_DEVIATION 5.15 | 31.1 years STANDARD_DEVIATION 5.2 |
| Ethnicity ( NIH/OMB) Hispanic | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity ( NIH/OMB) Non- Hispanic | 27 Participants | 55 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) White | 24 Participants | 48 Participants | 24 Participants |
| Region of Enrollment United States | 30 participants | 61 participants | 31 participants |
| Sex: Female, Male Female | 30 Participants | 61 Participants | 31 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 / 30 | 0 / 31 |
| other Total, other adverse events | 2 / 30 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 |
Outcome results
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.
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Lidocaine Patch | Total Dose of Opioids Received in the First 24 Hours Following Cesarean | 87 MME, morphine milligram equivalents | Standard Deviation 35.8 |
| Transdermal Hydrocolloid Placebo Patch | Total Dose of Opioids Received in the First 24 Hours Following Cesarean | 83.9 MME, morphine milligram equivalents | Standard Deviation 27.5 |
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.
Time frame: up to 24 hours
Population: Median Pain Scores Overall and by Prepregancy and Delivery Body Mass Index (BMI)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transdermal Lidocaine Patch | Post-operative Pain Score at 24 Hours Post-operatively | Pre pregnancy BMI 30-39.9 | 3.0 score on a scale |
| Transdermal Lidocaine Patch | Post-operative Pain Score at 24 Hours Post-operatively | Delivery BMI 30 -39.9 | 3.0 score on a scale |
| Transdermal Lidocaine Patch | Post-operative Pain Score at 24 Hours Post-operatively | Prepregancy BMI >40 | 4.0 score on a scale |
| Transdermal Lidocaine Patch | Post-operative Pain Score at 24 Hours Post-operatively | Delivery BMI >40 | 3.0 score on a scale |
| Transdermal Lidocaine Patch | Post-operative Pain Score at 24 Hours Post-operatively | Median Pain Score (0-10) | 3.0 score on a scale |
| Transdermal Hydrocolloid Placebo Patch | Post-operative Pain Score at 24 Hours Post-operatively | Delivery BMI >40 | 4.0 score on a scale |
| Transdermal Hydrocolloid Placebo Patch | Post-operative Pain Score at 24 Hours Post-operatively | Median Pain Score (0-10) | 3.5 score on a scale |
| Transdermal Hydrocolloid Placebo Patch | Post-operative Pain Score at 24 Hours Post-operatively | Pre pregnancy BMI 30-39.9 | 3.0 score on a scale |
| Transdermal Hydrocolloid Placebo Patch | Post-operative Pain Score at 24 Hours Post-operatively | Prepregancy BMI >40 | 4.0 score on a scale |
| Transdermal Hydrocolloid Placebo Patch | Post-operative Pain Score at 24 Hours Post-operatively | Delivery BMI 30 -39.9 | 3.0 score on a scale |
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
Time frame: up to 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Lidocaine Patch | Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge | 168.35 MME (mg) | Standard Deviation 120.4 |
| Transdermal Hydrocolloid Placebo Patch | Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge | 154.10 MME (mg) | Standard Deviation 93.9 |
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
Time frame: up to 120 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transdermal Lidocaine Patch | Length of Hospital Stay | 75.5 hours |
| Transdermal Hydrocolloid Placebo Patch | Length of Hospital Stay | 76 hours |
Other Pre-specified
Neonatal Outcomes: Gestational Age at Delivery
Gestational age at delivery will be recorded as weeks and days of gestation
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Lidocaine Patch | Neonatal Outcomes: Gestational Age at Delivery | 38.7 weeks | Standard Deviation 1.7 |
| Transdermal Hydrocolloid Placebo Patch | Neonatal Outcomes: Gestational Age at Delivery | 38.85 weeks | Standard Deviation 1.85 |
Other Pre-specified
Number of Opioid Pills Prescribed at Discharge
The number of opioid pills prescribed at discharge
Time frame: up to 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Lidocaine Patch | Number of Opioid Pills Prescribed at Discharge | 17.3 Number of pills | Standard Deviation 9 |
| Transdermal Hydrocolloid Placebo Patch | Number of Opioid Pills Prescribed at Discharge | 16.0 Number of pills | Standard Deviation 9.3 |
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)
Time frame: up to 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdermal Lidocaine Patch | Number of Participants With Complications of Lidocaine Use | 2 Participants |
| Transdermal Hydrocolloid Placebo Patch | Number of Participants With Complications of Lidocaine Use | 4 Participants |
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)
Time frame: up to 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdermal Lidocaine Patch | Number of Participants With Opioid-related Side Effects | 2 Participants |
| Transdermal Hydrocolloid Placebo Patch | Number of Participants With Opioid-related Side Effects | 4 Participants |
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)
Time frame: up to 120 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdermal Lidocaine Patch | Number of Participants With Postoperative Complications | 0 Participants |
| Transdermal Hydrocolloid Placebo Patch | Number of Participants With Postoperative Complications | 0 Participants |
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.
Time frame: up to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transdermal Lidocaine Patch | Time to First Rescue Opioid Analgesic Medication | 1.4 hours |
| Transdermal Hydrocolloid Placebo Patch | Time to First Rescue Opioid Analgesic Medication | 1.7 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.
Time frame: up to 120 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transdermal Lidocaine Patch | Total Dose of Opioids During the Whole Hospitalization. | 200 MME, morphine milligram equivalents |
| Transdermal Hydrocolloid Placebo Patch | Total Dose of Opioids During the Whole Hospitalization. | 192 MME, morphine milligram equivalents |
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
Time frame: up to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Lidocaine Patch | Total Dose of Opioids Used in the First 48 Hours Post-operatively | 149.3 MME, morphine milligram equivalents | Standard Deviation 58.5 |
| Transdermal Hydrocolloid Placebo Patch | Total Dose of Opioids Used in the First 48 Hours Post-operatively | 139.0 MME, morphine milligram equivalents | Standard Deviation 48.9 |