Cesarean Section; DehiscencePOPSNCT03829774
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
A study testing Primary Relief v 2.0 and Paracetamol in people with Cesarean Section; Dehiscence, run by DyAnsys, Inc. at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Dehiscence
- What is being tested?
- Primary Relief v 2.0 and Paracetamol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIndia
- Study dates
- 2 Jan 2019to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
- Congenital anomalies that may hamper the procedure (gastroschisis, amphalacele, spina bifida).
- Home birth.
- Severe mental health problem
- Hearing impairment.
- Legal abortion
- Twin pregnancy
- Instrumental birth
- Uterine anomalies with contraindication for vaginal birth. Eg: previous opening of uterine cavity, myomectomy, congenital abnormalities.
- Placenta anomalies.
- Placenta praevia, suspected acreta, increta, percreta especially after previous caesarean.
- Fetal abnormalities, growth restriction.
- Maternal complication with surgery.
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or subject or physician anticipates use of any of these therapies by the subject during the course of the study
- Previous participation in the Treatment Phase of this Protocol
- Malignant disease not in remission for five years or more that has been medically or surgically treated without evidence of metastases
- Presence of one or more medical conditions, as determined by medical history, which seriously compromises the subject's ability to complete the study, including history of poor adherence with medical treatment, unstable pain intensity or pain medications 6 weeks prior to the study, renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this study: a) One or more abnormal blood biochemistry analyte result that is ≥ 3 times that of the upper limit of the normal range
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV)
- American Heart Association (AHA) Class III and IV congestive heart failure (CHF), as defined by the following criteria: a) Class III: Symptoms with moderate exertion b) Class IV: Symptoms at rest or c) Cardiac pacemakers.
- Subjects with a diagnosis of psychiatric disorders such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, generalized anxiety, dysthymia or suicidality/suicide ideation
- Subjects not willing to undergo treatment before discharge from the hospital.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Clinic
Warangal, Telangana, 506002
Balachandran V, MD, 9496452707, v.balachandaran@dyansys.com
Robin M, GNM, 8722627172
About this study
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
- Being tested
- Primary Relief v 2.0, Paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Relief v 2.0Device
Also called Percutaeneous Nerve Field Stimulator Neurostimulator
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.
ParacetamolDrug
Also called Standard Drug Treatment for Postoperative pain
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Primary Relief v 2.0 |
| 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 Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours of device activation
Secondary outcomes (1)
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.
Measured: 2nd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start2 Jan 2019
- Primary completionMar 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DyAnsys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829774
- Sponsor's protocol ID
- CS/PRv2.0/C-Sec/2019
- Acronym
- POPS
- Status last verified
- Jan 2019
- First submitted
- 27 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32871021
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03829774
- Acronym / sponsor ID
- POPS / CS/PRv2.0/C-Sec/2019
- Conditions
- Cesarean Section; Dehiscence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- DyAnsys, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Relief v 2.0 Device | Experimental | Device: Primary Relief v 2.0The 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. |
| Paracetamol | Placebo comparator | Drug: ParacetamolA 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 |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (30 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Relief v 2.0Also: Percutaeneous Nerve Field Stimulator NeurostimulatorThe 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. | Device | Primary Relief v 2.0 Device |
| ParacetamolAlso: Standard Drug Treatment for Postoperative painA 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 | Drug | Paracetamol |
Primary outcome
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.
1 secondary outcome
Evaluate the impact of this treatment in terms of Quality Of Life
Time frame: 2nd day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 32871021Zimpel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Relief v 2.0 and Paracetamol in people with Cesarean Section; Dehiscence, run by DyAnsys, Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Balachandran V, MD (+91 9946452707, v.balachandran@dyansys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03829774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.