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| Name | Class |
|---|---|
| nCap Medical | INDUSTRY |
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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 NeuroCupleâ„¢ 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroCuple device | Active Comparator | Device placed by research personnel in PACU prior to transfer to the post-partum unit |
|
| Sham device | Sham Comparator | Device placed by research personnel in PACU prior to transfer to the post-partum unit |
|
| Standard of care | No Intervention | No device will be placed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroCuple | Device | Device around the abdomen over c-section bandages in the PACU |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Milligram Morphine Equivalents (MME) | Total opioid intake in MME on postoperative days 4 or before discharge. | Day of surgery to postop day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain reduction | Reduction (percentage decrease) in pain score (0-10 numeric rating scale) from day of surgery through postoperative day 4. | 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)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Saad, MD | Contact | 7037766040 | antonio.saad@inova.org | |
| Michelle Cassidy, phD | Contact | 7037764600 | michelle.cassidy@inova.org |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Saad, MD | Inova Health Care Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Medical Campus | Recruiting | Falls Church | Virginia | 22042 | United States |
Do not plan to share IPD
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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Subjects who agree to participate in the study will be randomized to one of 3 groups below in a 1:1:1 allocation
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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.
| Sham |
| Device |
Device around the abdomen over c-section bandages in the PACU |
|
| 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 | Day of surgery to postop day 4 |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |