NCT07185425

Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery

Management of Postoperative Pain After Cesarean Delivery Using Non-pharmacological Analgesic Device, NeuroCuple™

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	NeuroCuple	Device around the abdomen over c-section bandages in the PACU
DEVICE	Sham	Device around the abdomen over c-section bandages in the PACU

Timeline

• Start date: 2025-10-13
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-09-22
• Last updated: 2025-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study