Recruiting

NeuroCuple™

Sponsor:

Inova Health Care Services

Code:

NCT07185425

Conditions

Pain

Analgesia

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NeuroCuple

Sham

Study Details

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.

Conditions

Pain

Analgesia

Pregnancy

Study ID

NCT07185425

Start date

Oct 13, 2025

Status verified date

Oct, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: NeuroCuple device

Device placed by research personnel in PACU prior to transfer to the post-partum unit

sham comparator: Sham device

Device placed by research personnel in PACU prior to transfer to the post-partum unit

no intervention: Standard of care

No device will be placed

Interventions

NeuroCuple

Device around the abdomen over c-section bandages in the PACU

Sham

Device around the abdomen over c-section bandages in the PACU

Primary outcome measure

  • Total Milligram Morphine Equivalents (MME) [ Time Frame: Day of surgery to postop day 4 ]

Central Contacts and Locations

Central contacts

Antonio Saad, MD

7037766040antonio.saad@inova.org

Michelle Cassidy, phD

7037764600michelle.cassidy@inova.org

Locations

Inova Fairfax Medical Campus

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Antonio Saad, MD

703-776-6040antonio.saad@inova.org

Michelle Cassidy, PhD, RN

(703) 776-4600michelle.cassidy@inova.org

Principal Investigator:

Antonio Saad, MD

More Information

Sponsor

Inova Health Care Services

Last update posted

Oct 16, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2025-10-16.