TrueRelief Efficacy for Post-cesarean Pain (ELECTRON) (ELECTRON)

Non-invasive bioELEctroniC Treatment foR pOst-cesarean paiN (ELECTRON)

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 Overview

• Status: Completed
• Conditions: Post-cesarean Pain
• Intervention / Treatment: Device: TrueRelief device; Device: Sham TrueRelief device

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TrueRelief device; Patients receive an experimental procedure using a TrueRelief device.	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.
Sham Comparator: 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.	Device: Sham TrueRelief device; The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For primary day of cesarean to day of discharge (3 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After discharge through study completion, an average of six weeks
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.	At the discharge up to 24 hours
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,	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.	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
Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.		At hospital discharge

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: TrueRelief, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): March 16, 2023
• Study Completion (Actual): April 16, 2023

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Post-cesarean pain; Non-opioid; Non-invasive device
• Other Study ID Numbers: 2022H0046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes