TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

Not Applicable

Completed

Conditions: Post-cesarean Pain

Interventions: Device: TrueRelief device
Device: Sham TrueRelief device

Registration Number: NCT05250830

Lead Sponsor: Ohio State University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 134

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TrueRelief device	TrueRelief device	Patients receive an experimental procedure using a TrueRelief device.
Sham TrueRelief 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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	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.