To study and evaluate the Effectiveness of Treatment by Percutaneous Electrical NeuroStimulation (PENS) for post-operative pain in Cesarean Section patients using First Relief
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
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.
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
Clinic
Warangal, Telangana, India
RECRUITINGassessing the effects of PENS therapy in Postoperative period of Lower Segment Caesarean Section pain using VAS score.
To assess the effects of PENS therapy in Post-Operative period of Lower Segment Caesarean Section pain using the Visual Analogue Scale measurement. The level of pain is calculated from the VAS (Visual Analogue Scale) before the device is installed and assessed after 2 hours of the device activation. The pain level should be decreased when assessing after 2 hours of device installation. The score should be below 5. where 0 being no pain, 5 being moderate and 10 being maximum pain.
Time frame: 2 hours of device activation
Evaluate the impact of this treatment in terms of Quality Of Life
whether treatment can negate the need for more complex surgical treatments and/or reduce the need for drug treatment. Change in quality of life will be measured using the Evaluation form measurement.
Time frame: 2nd day
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