Analgesia, Pain, Pregnancy
Conditions
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.
Interventions
DEVICESham
Device around the abdomen over c-section bandages in the PACU
DEVICENeuroCuple
Device around the abdomen over c-section bandages in the PACU
Sponsors
nCap Medical
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactAntonio Saad, MD
Backup ContactMichelle Cassidy, phD
Outcome results
None listed