Non-invasive bioELEctroniC Treatment foR pOst-cesarean paiN (ELECTRON)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ohio State University
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
TrueRelief device
Patients receive an experimental procedure using a TrueRelief device.
Intervention: TrueRelief device (Device)
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.
Intervention: Sham TrueRelief device (Device)
Outcomes
Primary Outcomes
Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.
Time Frame: 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 Outcomes
- 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)
- Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.(At hospital discharge)
- 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)
- Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge.(At the discharge up to 24 hours.)
- 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)
Investigators
Kara M Rood, MD
Assistant Professor
Ohio State University