Post-cesarean Pain
Conditions
Keywords
Post-cesarean pain, Non-opioid, Non-invasive device
Brief summary
This is a randomized trial of 134 individualized post-cesarean delivery who will be randomized to twice daily use of non-invasive bioelectronic treatment with TrueRelief device or identical appearing sham device for post-cesarean pain management.
Interventions
DEVICETrueRelief device
TrueRelief is an FDA-cleared treatment for chronic intractable pain, and as an adjunctive procedure in the management of post-surgical and post-traumatic acute pain. This 20,000 Hz high frequency electrical procedure is provided by clinicians trained in the use of the device and delivered via handheld steel-tipped probes to the source of pain and where pain is experienced.
DEVICESham TrueRelief device
The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Sponsors
TrueRelief, LLC
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Double blind, randomized, sham-controlled trial parallel arm study using TrueRelief as the experimental treatment and a TrueRelief device with sham capabilities as a placebo.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
• Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) Singleton, or twin gestation
Exclusion criteria
* Known history of opioid use disorder, by medical record review * Contraindication to opioids * Contraindications to both acetaminophen and ibuprofen * Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different * Fetal or neonatal death prior to randomization * Inability to randomize on postoperative day 0 * Inability to participate in twice daily use of non-invasive bioelectronic treatment during inpatient stay as assessed by research staff * Language barrier (non-English or Spanish speaking) * Participation in another intervention study that influences the primary outcome in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups. | For primary day of cesarean to day of discharge (3 days) | The primary outcome is the total postoperative opioid intake through hospital discharge. All opioid doses were converted to equianalgesic doses of morphine sulfate MME using standard ratios. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge. | After discharge through study completion, an average of six weeks | Additional opioid prescriptions within 6 weeks postpartum in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing the number of opioid refill prescriptions. |
| Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | At the discharge up to 24 hours | Oral opioid prescribed at discharge as Morphine milligram equivalents (MME) in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator. |
| Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge. | At the discharge up to 24 hours. | The Brief Pain Inventory (BPI) includes self-assessment of pain scores in the previous 24 hours using a numerical scale from 0 to 10, with 0 representing no pain and 10 the worst pain imaginable. Moderate to severe pain (BPI score \>4) in past 24 h, |
| Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | After cesarean delivery until six weeks postpartum | Rate of wound infection or separation in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator groups. |
| Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | At hospital discharge | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TrueRelief Device Patients receive an experimental procedure using a TrueRelief device.
TrueRelief device: TrueRelief is an FDA-cleared treatment for chronic intractable pain, and as an adjunctive procedure in the management of post-surgical and post-traumatic acute pain. This 20,000 Hz high frequency electrical procedure is provided by clinicians trained in the use of the device and delivered via handheld steel-tipped probes to the source of pain and where pain is experienced. | 67 |
| Sham TrueRelief Device Patients receive a placebo procedure using a sham TrueRelief device that looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Sham TrueRelief device: The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current. | 67 |
| Total | 134 |
Baseline characteristics
| Characteristic | Sham TrueRelief Device | Total | TrueRelief Device |
|---|---|---|---|
| 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 | 67 Participants | 134 Participants | 67 Participants |
| Age, Continuous | 31.4 years STANDARD_DEVIATION 4.8 | 30.95 years STANDARD_DEVIATION 4.85 | 30.5 years STANDARD_DEVIATION 4.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 67 participants | 134 participants | 67 participants |
| Sex: Female, Male Female | 67 Participants | 134 Participants | 67 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 / 67 | 0 / 67 |
| other Total, other adverse events | 0 / 67 | 0 / 67 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 |
Outcome results
Primary
Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.
The primary outcome is the total postoperative opioid intake through hospital discharge. All opioid doses were converted to equianalgesic doses of morphine sulfate MME using standard ratios.
Time frame: For primary day of cesarean to day of discharge (3 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TrueRelief Device | Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups. | 19.75 Morphine milligram equivalents |
| Sham TrueRelief Device | Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups. | 37.50 Morphine milligram equivalents |
Secondary
Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
Time frame: At hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TrueRelief Device | Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | 59 Participants |
| Sham TrueRelief Device | Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | 57 Participants |
Secondary
Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
Oral opioid prescribed at discharge as Morphine milligram equivalents (MME) in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator.
Time frame: At the discharge up to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TrueRelief Device | Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | 82.50 Morphine milligram equivalents |
| Sham TrueRelief Device | Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | 90.00 Morphine milligram equivalents |
Secondary
Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge.
Additional opioid prescriptions within 6 weeks postpartum in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing the number of opioid refill prescriptions.
Time frame: After discharge through study completion, an average of six weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TrueRelief Device | Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge. | 1 Participants |
| Sham TrueRelief Device | Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge. | 7 Participants |
Secondary
Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge.
The Brief Pain Inventory (BPI) includes self-assessment of pain scores in the previous 24 hours using a numerical scale from 0 to 10, with 0 representing no pain and 10 the worst pain imaginable. Moderate to severe pain (BPI score \>4) in past 24 h,
Time frame: At the discharge up to 24 hours.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TrueRelief Device | Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge. | 57 Participants |
| Sham TrueRelief Device | Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge. | 61 Participants |
Secondary
Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
Rate of wound infection or separation in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator groups.
Time frame: After cesarean delivery until six weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TrueRelief Device | Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | 0 Participants |
| Sham TrueRelief Device | Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. | 2 Participants |