NSS-Bridge Device for Post-Cesarean Delivery Analgesia: A Randomized Controlled Trial

Area of Science:

• Obstetrics and Gynecology
• Pain Management
• Medical Devices

Background:

• Percutaneous auricular nerve stimulation (PANS) is used for opioid withdrawal symptoms.
• Its efficacy for post-surgical pain and opioid minimization remains uninvestigated.
• Cesarean delivery often requires opioid analgesia, posing risks for postpartum patients.

Purpose of the Study:

• To assess the feasibility and acceptability of a trial protocol for the NSS2-Bridge device.
• To evaluate the NSS2-Bridge as a non-pharmacologic alternative to opioids post-cesarean delivery.

Main Methods:

• A randomized controlled trial involving 60 healthy women undergoing cesarean delivery.
• Participants were assigned to active NSS2-Bridge device, placebo device, or no device for 5 days.
• Feasibility assessed via patient tolerability (VAS) and qualitative reports; outcomes included opioid-free hospitalization rates and pain levels.

Main Results:

• The NSS2-Bridge device demonstrated high tolerability (average VAS >75mm) and a high trial retention rate (89.7%).
• The active device group had the highest proportion of opioid-free hospitalizations (40%) compared to placebo (20%) and no device (30%).
• Pain levels at rest and with movement were comparable across all groups.

Conclusions:

• The trial protocol for the NSS2-Bridge device for post-cesarean pain management is feasible and acceptable.
• The increased proportion of opioid-free hospitalizations in the active device group warrants further investigation.
• The NSS2-Bridge device shows potential for managing pain in pregnant and postpartum individuals at high risk for opioid dependence.