NCT07185425

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable pain

Timeline
16mo left

Started Oct 2025

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Oct 2025Sep 2027

First Submitted

Initial submission to the registry

August 29, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

October 13, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

October 16, 2025

Status Verified

October 1, 2025

Enrollment Period

1.9 years

First QC Date

August 29, 2025

Last Update Submit

October 14, 2025

Conditions

PainAnalgesiaPregnancy

Outcome Measures

Primary Outcomes (1)

  • Total Milligram Morphine Equivalents (MME)

    Total opioid intake in MME on postoperative days 4 or before discharge.

    Day of surgery to postop day 4

Secondary Outcomes (3)

  • Pain reduction

    Day of surgery to postop day 4

  • Quality of Recovery

    Day of surgery to postop day 4

  • Opioid-related adverse events

    Day of surgery to postop day 4

Study Arms (3)

NeuroCuple device

ACTIVE COMPARATOR

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

Device: NeuroCuple

Sham device

SHAM COMPARATOR

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

Device: Sham

Standard of care

NO INTERVENTION

No device will be placed

Interventions

NeuroCupleDEVICE

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

NeuroCuple device
ShamDEVICE

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

Sham device

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

RECRUITING

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Antonio Saad, MD

    Inova Health Care Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Saad, MD

CONTACT

7037766040antonio.saad@inova.org

Michelle Cassidy, phD

CONTACT

7037764600michelle.cassidy@inova.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, investigators, and the clinical team (including obstetrics, anesthesia, operating room technicians nursing staff, and recovery and postpartum staff) will be blinded to the group assignment for the active and sham devices.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects who agree to participate in the study will be randomized to one of 3 groups below in a 1:1:1 allocation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 22, 2025

Study Start

October 13, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

October 16, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Do not plan to share IPD

Locations

US(1)