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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 Primary Relief v 2.0

NCT03829774 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-02-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • DyAnsys, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2019-03-31
Completion
2019-07-31

Countries

  • India

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829774 on ClinicalTrials.gov