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

NAUnknownINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

January 2, 2019

Primary Completion Date

March 31, 2019

Study Completion Date

July 31, 2019

Conditions
Cesarean Section; Dehiscence
Interventions
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

Trial Locations (1)

506002

RECRUITING

Clinic, Warangal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

DyAnsys, Inc.

INDUSTRY