Post-operative Pain, AcuteNCT06434714
Management of Postoperative Pain After Cesarean Delivery Using Bridge Auricular Percutaneous Nerve Field Stimulator
A study testing Auricular percutaneous nerve field stimulator in people with Post-operative Pain, Acute and Cesarean Section, run by Inova Health Care Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Acute, Cesarean Section, Opioid Use Disorder
- What is being tested?
- Auricular percutaneous nerve field stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
About this study
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.
Read the 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.
- Being tested
- Auricular percutaneous nerve field stimulator, Sham auricular percutaneous nerve field stimulator
- Keywords
- cesarean section, post-operative pain, opioid abuse, non-pharmacologic therapy
- Medical subject headings
- Pain, Postoperative, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular percutaneous nerve field stimulatorDevice
Also called Bridge
Percutaneous nerve field stimulator device placed on the ear for 5 days
Sham auricular percutaneous nerve field stimulatorDevice
Non-functioning percutaneous nerve field stimulator device placed on the ear for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Bridge device | Active comparator | Bridge device placed in post-anesthesia care unit (PACU) and worn until end-of-life of the device (at 5 days) in addition to standard of care pain medications as per institutional policy Receives: Device: Auricular percutaneous nerve field stimulator |
| Sham device | Sham comparator | Sham (non-functional) Bridge device placed in post-anesthesia care unit (PACU) and worn until 5 days post-delivery in addition to standard of care pain medications as per institutional policy Receives: Device: Sham auricular percutaneous nerve field stimulator |
| Standard of care | No intervention | Standard of care pain medications only as per institutional policy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid intake on post-operative day 4
Total opioid intake in morphine milligram equivalents (MME) on post-operative day 4
Measured: Four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study startJun 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-operative Pain, AcuteStudies 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
- Double-blinded, placebo-controlled, 3 arm randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Saad, MD, Principal investigator, Inova Health SystemsEllen M Murrin, DO, Principal investigator, Inova Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434714
- Sponsor's protocol ID
- INOVA-2023-131
- Status last verified
- Jan 2025
- First submitted
- 23 May 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Osmundson SS, Min JY, Grijalva CG. Opioid prescribing after childbirth: overprescribing and chronic use. Curr Opin Obstet Gynecol. 2019 Apr;31(2):83-89. doi: 10.1097/GCO.0000000000000527.
PubMed 30789842Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
PubMed 26996986Chelly JE, Monroe AL, Planinsic RM, Tevar A, Norton BE. Auricular field nerve stimulation using the NSS-2 BRIDGE(R) device as an alternative to opioids following kidney donor surgery. J Complement Integr Med. 2021 Nov 1;19(2):449-454. doi: 10.1515/jcim-2021-0208. eCollection 2022 Jun 1.
PubMed 34714990Lim G, LaSorda KR, Monroe AL, Chelly JE. Auricular percutaneous nerve field stimulator device as alternative therapy for Cesarean delivery analgesia: proof of concept. Can J Anaesth. 2019 Dec;66(12):1522-1523. doi: 10.1007/s12630-019-01465-x. Epub 2019 Aug 20. No abstract available.
PubMed 31432323
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Postoperative Pain After Cesarean Delivery Using Bridge Auricular Percutaneous Nerve Field Stimulator
- ClinicalTrials.gov ID
- NCT06434714
- Acronym / sponsor ID
- INOVA-2023-131
- Keywords
- cesarean section, post-operative pain, opioid abuse, non-pharmacologic therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 30 May 2024 (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.
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.
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
- Double-blinded, placebo-controlled, 3 arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Bridge device | Active comparator | Device: Auricular percutaneous nerve field stimulatorBridge device placed in post-anesthesia care unit (PACU) and worn until end-of-life of the device (at 5 days) in addition to standard of care pain medications as per institutional policy |
| Sham device | Sham comparator | Device: Sham auricular percutaneous nerve field stimulatorSham (non-functional) Bridge device placed in post-anesthesia care unit (PACU) and worn until 5 days post-delivery in addition to standard of care pain medications as per institutional policy |
| Standard of care | No intervention | –Standard of care pain medications only as per institutional policy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- Active drug abuse.
- Chronic opioid user.
- Severe chronic pain.
- Hemophilia.
- Cardiac pacemaker or implantable electronic devices.
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 |
|---|---|---|
| Auricular percutaneous nerve field stimulatorAlso: BridgePercutaneous nerve field stimulator device placed on the ear for 5 days | Device | Bridge device |
| Sham auricular percutaneous nerve field stimulatorNon-functioning percutaneous nerve field stimulator device placed on the ear for 5 days | Device | Sham device |
Primary outcome
Total opioid intake on post-operative day 4
Time frame: Four days
Total opioid intake in morphine milligram equivalents (MME) on post-operative day 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Background: PubMed 30789842Osmundson SS, Min JY, Grijalva CG. Opioid prescribing after childbirth: overprescribing and chronic use. Curr Opin Obstet Gynecol. 2019 Apr;31(2):83-89. doi: 10.1097/GCO.0000000000000527.
- Background: PubMed 26996986Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
- Background: PubMed 34714990Chelly JE, Monroe AL, Planinsic RM, Tevar A, Norton BE. Auricular field nerve stimulation using the NSS-2 BRIDGE(R) device as an alternative to opioids following kidney donor surgery. J Complement Integr Med. 2021 Nov 1;19(2):449-454. doi: 10.1515/jcim-2021-0208. eCollection 2022 Jun 1.
- Background: PubMed 31432323Lim G, LaSorda KR, Monroe AL, Chelly JE. Auricular percutaneous nerve field stimulator device as alternative therapy for Cesarean delivery analgesia: proof of concept. Can J Anaesth. 2019 Dec;66(12):1522-1523. doi: 10.1007/s12630-019-01465-x. Epub 2019 Aug 20. No abstract available.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Antonio Saad, MD principal investigator
Inova Health Systems
Ellen M Murrin, DO principal investigator
Inova Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular percutaneous nerve field stimulator in people with Post-operative Pain, Acute and Cesarean Section, 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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 3 Feb 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid intake on post-operative day 4 (time frame: Four days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06434714, which also lists 4 linked publications.
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 3 Feb 2025.