Adults 18 to 50, female only, with Post-cesarean Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.Primary· 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.
Group
Value
95% CI
TrueRelief Device
19.75
0 – 52.50
Sham TrueRelief Device
37.50
7.50 – 67.50
Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge.Secondary· 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.
Group
Value
95% CI
TrueRelief Device
1
Sham TrueRelief Device
7
Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.Secondary· 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.
Group
Value
95% CI
TrueRelief Device
82.50
0 – 90.00
Sham TrueRelief Device
90.00
75.00 – 90.00
Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge.Secondary· 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,
Group
Value
95% CI
TrueRelief Device
57
Sham TrueRelief Device
61
Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.Secondary· 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.
Group
Value
95% CI
TrueRelief Device
0
Sham TrueRelief Device
2
Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.Secondary· At hospital discharge
Group
Value
95% CI
TrueRelief Device
59
Sham TrueRelief Device
57
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ohio State University
Last refreshed: 6 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05250830.