Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery

Not Applicable

Not yet recruiting

• Conditions: Pain; Analgesia; Pregnancy

• Registration Number: NCT07185425
• Lead Sponsor: Inova Health Care Services

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.

Study Timeline

• Study First Submitted: 2025-08-29
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2027-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Milligram Morphine Equivalents (MME)	Day of surgery to postop day 4	Total opioid intake in MME on postoperative days 4 or before discharge.

Secondary Outcome Measures

Name	Time	Method
Pain reduction	Day of surgery to postop day 4	Reduction (percentage decrease) in pain score (0-10 numeric rating scale) from day of surgery through postoperative day 4.
Quality of Recovery	Day of surgery to postop day 4	Quality of recovery assessment evaluated on postoperative days 1-4 (Swedish Web Version of Quality of Recovery (SwQoR))
Opioid-related adverse events	Day of surgery to postop day 4	Overall incidence of opioid-related adverse effects including maternal PONV, sedation, constipation in POD 0-4

Trial Locations

Locations (1)

Inova Fairfax Medical Campus; 🇺🇸 Falls Church, Virginia, United States