Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery

NCT ID: NCT07185425

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2027-09-30

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.

Detailed Description

This is a single-center, sham-controlled, 3-arms, randomized, prospective study in 180 women undergoing cesarean delivery, with an expected subject enrollment duration of one year. Subjects will be screened and consented preoperatively before the scheduled case. Enrolled subjects will be randomized by research personnel using a computer generated randomization scheme in a 1:1:1 group allocation and assigned to the active device, sham device, or standard of care arms.

Upon arrival to the PACU, subjects in the standard-of-care arm will receive standard postoperative pain orders at the discretion of the primary OB/GYN. For subjects in the active and sham device arms, device will be placed as soon as feasible in the PACU and before transfer to the post-partum floor by trained research staff. Both patients and the clinical team will be blinded to the group assignment for the active and sham devices.

Pain scores will be collected from the study participants per nursing protocols while inpatient, and daily after discharge until postoperative day 4, using the Pain Numeric Rating Scale. For breakthrough pain, patients may use oral or IV opioids in the inpatient setting and oral opioids in the outpatient setting.

Upon discharge, patients are typically prescribed an opioid medication. However, this will also be left to the discretion of the primary OB/GYN. In this study, the investigators will examine total milligram morphine equivalent (MME) opioid intake at postoperative day 4 or before discharge as the primary endpoint, reduction (percentage change) in numeric pain scale as the secondary endpoint, and change in quality of recovery as the exploratory endpoint.

Conditions

Pain; Analgesia; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NeuroCuple device

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

Group Type: ACTIVE_COMPARATOR

NeuroCuple

Intervention Type: DEVICE

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

Sham device

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

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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

Standard of care

No device will be placed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NeuroCuple

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

Intervention Type: DEVICE

Sham

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

nCap Medical

INDUSTRY

Sponsor Role: collaborator

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Saad, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Health Care Services

Locations

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Antonio Saad, MD

Role: CONTACT

antonio.saad@inova.org

7037766040

Michelle Cassidy, phD

Role: CONTACT

michelle.cassidy@inova.org

7037764600

Facility Contacts

Antonio Saad, MD

Role: primary

antonio.saad@inova.org

703-776-6040

Michelle Cassidy, PhD, RN

Role: backup

michelle.cassidy@inova.org

(703) 776-4600

Other Identifiers

INOVA-2025-16

Identifier Type: -

Identifier Source: org_study_id