Cesarean Section, Opioids; Harmful Use, Opioid Use Disorder, Post-operative Pain, Acute
Conditions
Keywords
cesarean section, post-operative pain, opioid abuse, non-pharmacologic therapy
Brief summary
Post-cesarean section (CS) pain is commonly treated with acetaminophen, ibuprofen, and opioid medications as needed following delivery. About 300,000 women annually who were exposed to opioids after CS will go on to use opioids chronically. Reducing the quantity of post-CS opioids has been shown to decrease the amount of opioids used without compromising pain control. Bridge is a small device that sits on the outer ear and works similarly to a transcutaneous electrical nerve stimulation (TENS) unit to decrease pain sensation without medications. It has been shown to effectively reduce pain to decrease medication requirements after surgeries. This study aims to see if women receiving the Bridge device use need less pain medication than those without the device.
Detailed description
Cesarean delivery is one of the most performed surgeries in the U.S. with approximately 1.15 million surgeries performed annually. Despite this, postoperative pain management remains a challenge. Prescribed total milligram morphine equivalents (MMEs) can range from 25 MMEs (equivalent to 3.3 oxycodone 5-mg tablets) to 1,950 MMEs (equivalent to 260 oxycodone 5-mg tablets). Additionally, the post discharge analgesia prescription is not correlated with the 24-hour predischarge opioid use or pain score. Most U.S. women who are prescribed opioids after a cesarean delivery receive at least 10 more tablets than necessary. A study looking at individualizing opioid prescriptions based on inpatient requirements found that women used about 60% of their prescription, regardless of the amount of opioids prescribed. Decreasing opioid requirement after cesarean delivery, can decrease women's exposure to opioids, reduce the risk of neonatal central nervous system depression due to exposure in breastmilk, and limit the potential for extra opioids from unused, filled prescriptions to fall into the wrong hands. Post-cesarean mothers use opioids for a median of 8 days after delivery. Bridge is a minimally invasive device shown in previous studies to reduce pain medication requirements in the post-operative acute recovery period. The device is a auricular percutaneous electrical nerve stimulator that modulates pain receptors leading to reduced pain sensation. This trial study to examine the utility of the Bridge device as an adjunct to standard of care post-cesarean pain regimens (acetaminophen, ibuprofen or ketorolac, and oxycodone or other similar opioid). Post-cesarean patients will be randomized in a 1:1:1 ratio to Bridge device, sham device, or standard of care treatment and followed through the postpartum period.
Interventions
DEVICEAuricular percutaneous nerve field stimulator
Percutaneous nerve field stimulator device placed on the ear for 5 days
DEVICESham auricular percutaneous nerve field stimulator
Non-functioning percutaneous nerve field stimulator device placed on the ear for 5 days
Sponsors
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will be randomized to either active Bridge device, sham (non-functional) device, or standard of care post-operative pain regimen. Participants, care providers, and investigators will be blinded to those in active or sham device groups.
Intervention model description
Double-blinded, placebo-controlled, 3 arm randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Female 18 years or older able to provide informed consent in English or Spanish. * Scheduled for cesarean delivery under neuraxial anesthesia. * Intact skin surface behind and around the ear at the site of electrode application.
Exclusion criteria
* Active drug abuse. * Chronic opioid user. * Severe chronic pain. * Hemophilia. * Cardiac pacemaker or implantable electronic devices. * Psoriasis vulgaris or other skin conditions precluding safe device application. * Previous history of sensitivity to compound benzoin tincture. * Hearing aid precluding proper placement of the device or removing which interferes with their hearing ability. * 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 opioid intake on post-operative day 4 | Four days | Total opioid intake in morphine milligram equivalents (MME) on post-operative day 4 |
Countries
United States
Outcome results
None listed