PainNCT07185425
Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery
A study testing NeuroCuple in people with Pain and Analgesia, run by Inova Health Care Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- NeuroCuple
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Antonio Saad, MD, 703-776-6040, antonio.saad@inova.org
Michelle Cassidy, PhD, RN, (703) 776-4600, michelle.cassidy@inova.org
About this study
Official title: Management of Postoperative Pain After Cesarean Delivery Using Non-pharmacological Analgesic Device, NeuroCuple™
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.
Read the 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.
- Being tested
- NeuroCuple, Sham
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroCupleDevice
Device around the abdomen over c-section bandages in the PACU
ShamDevice
Device around the abdomen over c-section bandages in the PACU
| Study group | Role | What they receive |
|---|---|---|
| NeuroCuple device | Active comparator | Device placed by research personnel in PACU prior to transfer to the post-partum unit Receives: Device: NeuroCuple |
| Sham device | Sham comparator | Device placed by research personnel in PACU prior to transfer to the post-partum unit Receives: Device: Sham |
| Standard of care | No intervention | No device will be placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Milligram Morphine Equivalents (MME)
Total opioid intake in MME on postoperative days 4 or before discharge.
Measured: Day of surgery to postop day 4
Secondary outcomes (3)
Pain reduction
Reduction (percentage decrease) in pain score (0-10 numeric rating scale) from day of surgery through postoperative day 4.
Measured: Day of surgery to postop day 4
Quality of Recovery
Quality of recovery assessment evaluated on postoperative days 1-4 (Swedish Web Version of Quality of Recovery (SwQoR))
Measured: Day of surgery to postop day 4
Opioid-related adverse events
Overall incidence of opioid-related adverse effects including maternal PONV, sedation, constipation in POD 0-4
Measured: Day of surgery to postop day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start13 Oct 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects who agree to participate in the study will be randomized to one of 3 groups below in a 1:1:1 allocation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- nCap Medical
- Responsible party
- Sponsor
- Investigators
- Antonio Saad, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185425
- Sponsor's protocol ID
- INOVA-2025-16
- Status last verified
- Oct 2025
- First submitted
- 29 Aug 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Do not plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Postoperative Pain After Cesarean Delivery Using Non-pharmacological Analgesic Device, NeuroCuple™
- ClinicalTrials.gov ID
- NCT07185425
- Acronym / sponsor ID
- INOVA-2025-16
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- nCap Medical
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects who agree to participate in the study will be randomized to one of 3 groups below in a 1:1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| NeuroCuple device | Active comparator | Device: NeuroCupleDevice placed by research personnel in PACU prior to transfer to the post-partum unit |
| Sham device | Sham comparator | Device: ShamDevice placed by research personnel in PACU prior to transfer to the post-partum unit |
| Standard of care | No intervention | –No device will be placed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroCupleDevice around the abdomen over c-section bandages in the PACU | Device | NeuroCuple device |
| ShamDevice around the abdomen over c-section bandages in the PACU | Device | Sham device |
Primary outcome
Total Milligram Morphine Equivalents (MME)
Time frame: Day of surgery to postop day 4
Total opioid intake in MME on postoperative days 4 or before discharge.
3 secondary outcomes
Pain reduction
Time frame: Day of surgery to postop day 4
Quality of Recovery
Time frame: Day of surgery to postop day 4
Opioid-related adverse events
Time frame: Day of surgery to postop day 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Do not plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Saad, MD principal investigator
Inova Health Care Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroCuple in people with Pain and Analgesia, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Saad, MD (7037766040, antonio.saad@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Milligram Morphine Equivalents (MME) (time frame: Day of surgery to postop day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.