Noninvasive Bioelectronic Treatment of Postcesarean Pain: A Randomized Clinical Trial
Authors' conclusion
In this randomized clinical trial of postoperative patients following cesarean delivery, use of a high-frequency electrical stimulation device as part of a multimodal analgesia protocol decreased opioid use in the immediate postoperative period and opioids prescribed at discharge.
Study context
- Population
- Individuals with singleton or twin gestation undergoing cesarean delivery, single tertiary academic medical center in Ohio1 sham withdrew before treatment
- Participants
- 134 individuals
- Comparison
- Functional device vs Sham device
- Functional devicen = 67
- Sham devicen = 67reference
- Primary endpoint
- Inpatient postoperative opioid use (morphine milligram equivalents (MME))
Methodological detailstriple-blind, sham-controlled, single-centre
- Triple-blind
- Sham-controlled
- Single-centre
Primary result
As reported in the abstract
Inpatient opioid use prior to discharge
P = 0.046
Secondary outcomes
| Outcome | Functional device | Sham device | RR (95% CI) | P value | |
|---|---|---|---|---|---|
| Moderate to severe pain | 85% | 91% | 0.77 (0.55–1.29) | P = 0.43 | |
| Discharged without opioid prescription | 25% | 10% | 1.58 (1.08–2.13) | P = 0.03 | |
| 0.512Relative risk (log scale) |
MME prescribed at discharge
P < 0.001
Mean
| Outcome | Functional device | Sham device | P value |
|---|---|---|---|
| Pain score (Brief Pain Inventory, 0-10) | 3.59 (95% CI 3.21–3.98) | 4.46 (95% CI 4.01–4.92) | P = 0.004 |
Safety
Events
| Outcome | Functional device | Sham device |
|---|---|---|
| Treatment-related adverse events | 0 | 0 |
Original publication
Noninvasive Bioelectronic Treatment of Postcesarean Pain: A Randomized Clinical Trial. JAMA Netw Open. Published 2 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →