Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Pain, Analgesia, Pregnancy

In brief

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.

Key facts

Study ID

NCT07185425

Run by

Inova Health Care Services

People needed

180

Starts

2025-10-13

Expected to finish

2027-09-01

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Inova Fairfax Medical Campus — Falls Church, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.