TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

Post-cesarean Pain Clinical Trial

— ELECTRON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05250830
• Other study ID #: 2022H0046
• Status: Completed
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: April 16, 2023

Study information

• Verified date: May 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-cesarean Pain

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	TrueRelief, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	For primary day of cesarean to day of discharge (3 days)
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.	After discharge through study completion, an average of six weeks
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.	At the discharge up to 24 hours
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,	At the discharge up to 24 hours.
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.	After cesarean delivery until six weeks postpartum
Secondary	Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.		At hospital discharge