N/A
Completed N=60
BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control
Opioid Use Disorder · Pain, Postoperative
Source: ClinicalTrials.gov NCT04365465 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Pain Scores With Movement — 4.57; 4.61; 4.19 score on a scale
Summary
This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD). The purpose of this pilot investigation is to establish feasibility/acceptability of the trial design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores With Movement |
4.57; 4.61; 4.19 | — |
| SECONDARY PROMIS Pain Intensity Survey |
8.23; 7.9; 7.8 | — |
| SECONDARY PROMIS Pain Interference Survey |
9.47; 9.0; 9.0 | — |
| SECONDARY Opioid Consumption |
8; 4; 6; 12; 16; 14 | — |
| SECONDARY ObsQoR-11 Survey |
79.32; 76.9; 80.3 | — |
| SECONDARY Recovery Variables From Med Record: ICU Admission |
0; 0; 0 | — |
| SECONDARY Recovery Variables From Med Record: Readmission |
0; 0; 0 | — |
| SECONDARY Recovery Variables From Med Record: Readmission Due to Pain Issues |
0; 0; 0 | — |
| SECONDARY BPI8 Survey |
8.5; 8.3; 2.9 | — |
| SECONDARY BPI25 Survey |
2.91; 2.93; 2.93 | — |
| SECONDARY Device Tolerability Survey |
76.8; 80.1 | — |
Eligibility Criteria
Inclusion Criteria
- Pregnant
- Third trimester
- Cesarean delivery under neuraxial anesthesia
- Healthy, clean skin
- 18 years or older
Exclusion Criteria
- Not fluent in English (surveys are validated in English language), unable to participate in informed consent discussions, or unable to give informed consent for any reason
- Unable to participate fully in all study procedures for any reason
- Cesarean delivery under general anesthesia
- History of hemophilia
- Pacemakers or implantable electronic devices
- History of psoriasis
Data sourced from ClinicalTrials.gov (NCT04365465). 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. Informational only — not medical advice.