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
Overview
- Phase
- N/A
- Intervention
- Primary Relief v 2.0
- Conditions
- Cesarean Section; Dehiscence
- Sponsor
- DyAnsys, Inc.
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- assessing the effects of PENS therapy in Postoperative period of Lower Segment Caesarean Section pain using VAS score.
- Last Updated
- 7 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age range between 22 - 35 years
- •Patient willing to undergo C-section surgery
- •Patient having pains after one hour of post C-Section surgery
- •Patients who is conscious and oriented for device installation after anesthetic effect
- •Patient who completed required clinical and biochemical investigations as deemed necessary by the gynecologist after post C - section surgery.
- •No previous poor obstetrical outcome
- •No experience in Han's Acupoint nerve stimulator and TENS for other reasons.
- •Term pregnancy (\> 37 weeks of gestation).
- •Understands and is willing to participate in the clinical study and can comply with study procedures.
- •Normal cognitive and communicative ability as judged by clinical assessment and ability to complete self-reported questionnaires.
Exclusion Criteria
- •Had been diagnosed with other diseases such as preoperative presence of maternal mental, neurological disease, affecting evaluation of pains and disease condition.
- •Had combined with gestational hypertension, gestational diabetes, gestational thyroid disease.
- •Had taken analgesic drugs
- •Had used diazepam, piperazine hydrochloride or other sedative, analgesic drugs in the stage of labor.
- •Were overweight or low pregnancy weight, Body mass index (\< 18.5 or \>25 kg/m2).
- •Patients who are not agreeing to receive painless labor and not sign the informed consent form.
- •Neonatal problem requiring immediate separation from the mother for medical care or NICU admittance.
- •Severe placental abruption.
- •Hydrops (accumulation of fluid or edema in fetus body tissue and cavities) if secondary to anemia or heart failure.
- •Known twin to twin transfusion syndrome (TTS).
Arms & Interventions
Primary Relief v 2.0 Device
The test product or device called Primary Relief v 2.0 device 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.
Intervention: Primary Relief v 2.0
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
Intervention: Paracetamol
Outcomes
Primary Outcomes
assessing the effects of PENS therapy in Postoperative period of Lower Segment Caesarean Section pain using VAS score.
Time Frame: 2 hours of device activation
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.
Secondary Outcomes
- Evaluate the impact of this treatment in terms of Quality Of Life(2nd day)