TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

NCT05250830 | Completed Results FDA Device

• 1 other identifier: 2022H0046
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-cesarean Pain

Keywords

Post-cesarean pain; Non-opioid; Non-invasive device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.

  At hospital discharge

Study Arms (2)

TrueRelief device

EXPERIMENTAL

Patients receive an experimental procedure using a TrueRelief device.

Device: TrueRelief device

Sham TrueRelief device

SHAM COMPARATOR

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

Interventions

TrueRelief device 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.

TrueRelief device

Sham TrueRelief device DEVICE

The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.

Sham TrueRelief device

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) Singleton, or twin gestation

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• TrueRelief, LLC: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210, United States

Location

Results Point of Contact

• Title: Kara Rood
• Organization: The Ohio State University

Kara.Rood@osumc.edu

440-321-0264

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 22, 2022
• Study Start: April 18, 2022
• Primary Completion: March 16, 2023
• Study Completion: April 16, 2023
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)