NCT07185425 Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery
| NCT ID | NCT07185425 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inova Health Care Services |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-10-13 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This will be a single-center, sham-controlled, 3 arms, randomized (1:1:1) prospective study in females undergoing cesarean delivery to investigate the impact of NeuroCuple™ non-pharmacological analgesic device for management of postoperative pain. The investigators hypothesize that women treated with the Neurocuple device will experience less pain and consequently require less opioid pain medication after cesarean delivery compared to women who receive standard post-surgical medication.
Eligibility Criteria
Inclusion Criteria: * Female 18 years or older able to provide informed consent in English or Spanish * Scheduled for a planned or unplanned non-emergent cesarean delivery under neuraxial anesthesia * Intact skin surfaces around the operative skin incision area at the site of patch application * Pfannestiel skin incision Exclusion Criteria: * Active drug abuse * Chronic opioid user * Severe chronic pain * Psoriasis vulgaris or other skin conditions precluding safe device application * Subject is concurrently participating in another research study with an investigational drug or medical device that in the Investigator's opinion could impact subject safety or study results * Subject with reasons to maintain an epidural beyond operative room * Subject with complex surgery or subject who may need more than a cesarean surgery with possible tubal sterilization procedure * Subject is deemed not suitable for the study at the discretion of the principal Investigator
Contact & Investigator
Antonio Saad, MD
PRINCIPAL INVESTIGATOR
Inova Health Care Services
Frequently Asked Questions
Who can join the NCT07185425 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07185425 currently recruiting?
Yes, NCT07185425 is actively recruiting participants. Contact the research team at antonio.saad@inova.org for enrollment information.
Where is the NCT07185425 trial being conducted?
This trial is being conducted at Falls Church, United States.
Who is sponsoring the NCT07185425 clinical trial?
NCT07185425 is sponsored by Inova Health Care Services. The principal investigator is Antonio Saad, MD at Inova Health Care Services. The trial plans to enroll 180 participants.