BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

Pain, Postoperative Clinical Trial

Official title:

BRIDGE Device: Percutaneous Auricular Nerve Field Stimulation as Alternative Post-Cesarean Delivery Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365465
• Other study ID #: STUDY19110257
• Secondary ID: UL1TR001857
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD). The purpose of this pilot investigation is to establish feasibility/acceptability of the trial design.

Description:

This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control). The devices will be placed while women are still feeling pain relief from labor epidural analgesia (after delivering vaginally) or from spinal or epidural anesthesia (after delivering by cesarean). By applying the devices while women are still relatively pain-free, a preventative/pre-emptive approach to pain management in women at risk for severe postpartum pain is taken. The study will enroll women with and without OUD and follow them for five days postpartum.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant
• Third trimester
• Cesarean delivery under neuraxial anesthesia
• Healthy, clean skin
• 18 years or older

Exclusion Criteria:

• Not fluent in English (surveys are validated in English language), unable to participate in informed consent discussions, or unable to give informed consent for any reason
• Unable to participate fully in all study procedures for any reason
• Cesarean delivery under general anesthesia
• History of hemophilia
• Pacemakers or implantable electronic devices
• History of psoriasis

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Pain, Postoperative

Intervention

Device:
• NSS-2 Bridge
The NSS-2 BRIDGE (Appendix 1) is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs.
• Inactive NSS-2 Bridge
This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.

Other:
• Active control
Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.

Locations

Country	Name	City	State
United States	UPMC Magee Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Grace Lim, MD, MS	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores With Movement	Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.	post-operative day 3
Secondary	PROMIS Pain Intensity Survey	PROMIS Pain Intensity Survey is self-reported by participants and includes the options: "Had no pain", "Mild", "Moderate", "Severe", or "Very Severe". These responses range from 1 point (had no pain) to 5 points (very severe). This means the participant raw score can be between 3 points and 15 points.	Post-operative day 3
Secondary	PROMIS Pain Interference Survey	PROMIS Pain Interference Survey is self-reported by participants and includes the options: "Not at all", "A little bit", "Somewhat", "Quite a bit", or "Very Much". These responses range from 1 point (not at all) to 5 points (very much). This means the participant raw score can be between 3 points and 15 points.	Post-operative day 3
Secondary	Opioid Consumption	Total opioid consumption as abstracted from EMR during hospital stay. The number of participants using opioids by post-operative day 3 will be recorded by binary responses of 'yes' or 'no' via EMR data.	Post-operative day 3
Secondary	ObsQoR-11 Survey	11 item survey evaluation of postoperative symptoms and independence as self reported by participants. Scale for this tool is 0-10 with 0 being "very poor" and 10 being "excellent". Total score will be calculated for each participant. Minimum score = 0 and Maximum score = 110	Post-operative day 3
Secondary	Recovery Variables From Med Record: ICU Admission	ICU admission as abstracted from EMR during hospital stay. This will be recorded with a binary response of 0. no or 1. yes if participant is admitted to the ICU in the first week post-op.	First week postoperatively
Secondary	Recovery Variables From Med Record: Readmission	Readmission as abstracted from EMR during hospital stay.	First week postoperatively
Secondary	Recovery Variables From Med Record: Readmission Due to Pain Issues	Readmission due to pain issues as abstracted from EMR during hospital stay.	First week postoperatively
Secondary	BPI8 Survey	1 item survey of percentage of relief experienced from pain management as self-reported by participants. Percentage options: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100. Participant will self-report on post-operative day 3. Percentages will be converted to a 0-10 scale. A score of 0 (minimum value) indicates better outcomes and a score of 10 (maximum value) indicates worse outcomes	Post-operative day 3
Secondary	BPI25 Survey	1 item survey of pain medication use frequency as self-reported by participants. Scored on a 1-5 scale, with 1 indicating better outcomes and 5 indicating worse outcomes.	Post-operative day 3
Secondary	Device Tolerability Survey	Device tolerability will be recorded using a Visual Analogue Scale (VAS). This will be self-reported by participants. Response options: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100. 0 = no pain at all and 100 = severe intolerable pain.	Post-Op Day 7