NCT03829774

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 5, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

January 27, 2019

Last Update Submit

February 1, 2019

Conditions

Cesarean Section; Dehiscence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Evaluate the impact of this treatment in terms of Quality Of Life

    2nd day

Study Arms (2)

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.

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

Drug: Paracetamol

Interventions

Primary Relief v 2.0DEVICE

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.

Also known as: Percutaeneous Nerve Field Stimulator Neurostimulator
Primary Relief v 2.0 Device
ParacetamolDRUG

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

Also known as: Standard Drug Treatment for Postoperative pain
Paracetamol

Eligibility Criteria

Age22 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Women willing to undergo C-Section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • Congenital anomalies that may hamper the procedure (gastroschisis, amphalacele, spina bifida).
  • Home birth.
  • Severe mental health problem
  • Hearing impairment.
  • Legal abortion
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic

Warangal, Telangana, 506002, India

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32871021DERIVED

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Balachandran V, MD

CONTACT

+91 9946452707v.balachandran@dyansys.com

Hariharan A, B.Tech

CONTACT

+91 8124147672a.hariharan@dyansys.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2019

First Posted

February 4, 2019

Study Start

January 2, 2019

Primary Completion

March 1, 2019

Study Completion

July 1, 2019

Last Updated

February 5, 2019

Record last verified: 2019-01

Locations

IN(1)