N/A
N=134
TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)
Post-cesarean Pain
Bottom Line
View on ClinicalTrials.gov: NCT05250830 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups. — 19.75; 37.50 Morphine milligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TrueRelief device (Device); Sham TrueRelief device (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ohio State University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups. |
19.75; 37.50 | — |
| SECONDARY Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge. |
1; 7 | — |
| SECONDARY Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. |
82.50; 90.00 | — |
| SECONDARY Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge. |
57; 61 | — |
| SECONDARY Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. |
0; 2 | — |
| SECONDARY Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups. |
59; 57 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05250830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.