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To study and evaluate the Effectiveness of Treatment by Percutaneous Electrical NeuroStimulation (PENS) for post-operative pain in Cesarean Section patients using First Relief
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Relief v 2.0 Device | Experimental | 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. |
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| Paracetamol | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Relief v 2.0 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| assessing 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. | 2 hours of device activation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2nd day |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant Women willing to undergo C-Section
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Balachandran V, MD | Contact | +91 9946452707 | v.balachandran@dyansys.com | |
| Hariharan A, B.Tech | Contact | +91 8124147672 | a.hariharan@dyansys.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic | Recruiting | Warangal | Telangana | 506002 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32871021 | Derived | Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2. |
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| Paracetamol | Drug | 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 |
|
|
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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