NCT03829774

To Study and Evaluate the Effectiveness of Treatment by Percutaneous Electrical NeuroStimulation (PENS) for Post-operative Pain in Cesarean Section Patients Using Primary Relief v 2.0

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: DyAnsys, Inc. · Industry
• Sex: Female
• Age: 22 Years – 35 Years
• Healthy volunteers: Accepted

Summary

To study and evaluate the Effectiveness of Treatment by Percutaneous Electrical NeuroStimulation (PENS) for post-operative pain in Cesarean Section patients using First Relief

Conditions

• Cesarean Section; Dehiscence

Interventions

Type	Name	Description
DEVICE	Primary Relief v 2.0	The test product or device called Primary Relief v 2.0 will be used for the study. The study will be conducted for a period of two to three months with the treatment period of 3 - 4 days i.e single treatment (installation). The additional time taken will be to define the characteristics of the patient population and to recruit appropriate patients. Finally, there will be a data analysis and report writing period. Overall, the study is expected to 3 months. The device will be placed onto the auricle part of the ear for percutaneous electrical nerve stimulation.
DRUG	Paracetamol	A control group, receiving a standard treatment as follows: primary choice of analgesic was intravenous paracetamol, 1 gram, and if the pain relief was inadequate, diclofenac inj. If pain persisted in spite of these measures, 50 mg tramadol was administered intravenously

Timeline

• Start date: 2019-01-02
• Primary completion: 2019-03-01
• Completion: 2019-07-01
• First posted: 2019-02-04
• Last updated: 2019-02-05

Locations

1 site across 1 country: India