AzTrials
AzTrials

Cancer of EndometriumNCT05742711

Efficacy of PENS of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix Patients

A study testing Primary Relief in people with Cancer of Endometrium and Cancer of Cervix, run by DyAnsys, Inc. at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Pain relief following laparotomy surgery requires a variety of techniques including invasive ones like epidural or nerve blocks along with different classes of drugs, out of which opioids are most predominant. Each of these drugs have with their own set of advantages and also side effects. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cancer of Endometrium, Cancer of Cervix
What is being tested?
Primary Relief
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteIndia
Study dates
16 May 2023to 13 Jan 2025
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >18 yrs
  • Diagnosed with CA-endometrium OR CA -cervix of stage I/II and post RT CA cervix patients coming for hysterectomy
  • Elective surgery
  • Informed consent obtained
  • ASA (American Society of Anaesthesiology) physical status 1-3

Who cannot join

  • Patient refusal
  • Cancer cervix other than the stages mentioned in inclusion criteria ASA PS >3
  • Emergency surgery, Laparoscopic and robotic procedures
  • Unplanned postoperative ventilation
  • Allergy/sensitivity to adhesive
  • Active skin infection/lesion in the ear region
Show all 15Show fewer
  • H/O of seizure or cerebral disease
  • H/O chronic pain and prolonged analgesic usage
  • H/O opioid dependence
  • H/O anxiety or psychiatric illness requiring treatment
  • Pre-existing implantable/ electronic on demand device
  • Patients who might require MRI in the study period
  • Patients with transmissible diseases
  • Patients with coagulopathies
  • Absolute or relative contraindication to drugs used in the study

Trial locations and contacts

1 site in 1 country.

India1 site

  • Cancer Institute,(Wia)

    Chennai, Tamil Nadu, 600020

Other trials in India

About this study

Official title: Efficacy of Percutaneous Electrical Neurostimulation (PENS)of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix

Pain relief following laparotomy surgery requires a variety of techniques including invasive ones like epidural or nerve blocks along with different classes of drugs, out of which opioids are most predominant. Each of these drugs have with their own set of advantages and also side effects. An ideal common system of analgesia is not possible due to patient variability. And no drug is devoid of side effects. Hence the aim is to ensure effective analgesia using drugs or techniques which are minimally invasive with negligible side effects.

Read the detailed description

Efficient post operative pain relief is an essential part of comprehensive recovery of patients. Conventional method of pain management of laparotomy surgeries in CA endometrium and cervix patients involves invasive techniques like epidural or selective nerve block coupled with a varied choice of analgesics like opioids, NSAID or acetaminophen, wherein each drug is associated with its own set of contraindications and side effects. Despite advances in analgesic regimen including multimodal analgesic regimen, opioids have been observed to remain the mainstay postoperative analgesia in cancer patients despite its well-established side effects.

This double-blinded prospective interventional study is conducted to explore the alternative of percutaneous electrical nerve stimulation (PENS) devices for effective pain relief with minimal to no side-effects.

The device will have tiny needles and a battery system that will be placed on and behind the patient's ear when they are under anesthesia.

It acts by stimulating nerves around ear region by series of pain free impulse generation leading to centrally (brain) mediated response by altering certain chemical substances responsible for causing pain thereby providing relief for the patient.

Being tested
Primary Relief, Primary Relief - Sham Device
Medical subject headings
Endometrial Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Primary ReliefDevice

    Also called Percutaneous Electrical Nerve Stimulator (PENS)

    Continuous neurostimulation with a set of pre-assigned stimulation parameters.

  • Primary Relief - Sham DeviceDevice

    Also called Standard Treatment for Postoperative Pain

    Standard treatment with the application of sham device shall be followed with additional analgesics available if necessary.

Study groups in NCT05742711
Study groupRoleWhat they receive
Treatment GroupExperimentalThe group who have received PENS treatment using PrimaryRelief in addition to Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS>4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain.
Receives: Device: Primary Relief
Control GroupSham comparatorThe group who have received a sham device along with Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS>4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain.
Receives: Device: Primary Relief - Sham Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Rating Scale (NRS)

    The primary goal is to evaluate the efficacy of PENS treatment in the change in postoperative pain after cancer surgery compared to the control group. The pain is measured using the numerical rating scale (NRS). Pain Score will be measured on a scale (0 = no pain;10 = worst imaginable pain; lower scores indicate better outcome)

    Measured: 0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours. Outcomes will be reported as an average over each individual postoperative day and as an average over 5 days independently for rest.

Secondary outcomes (7)

  1. Overall Postoperative analgesia and opioid requirement

    To evaluate the effect of treatment in reducing the overall postoperative analgesia and opioid requirement. We will record the total dose and duration of additional analgesics required from the immediate postoperative period till pod 4 in iv morphine equivalents.

    Measured: 0 - 4 days, duration and dose of all prescriptions are recorded.

  2. Patient Ambulation

    Evaluate the ease of patient ambulation by assessing associated Numeric Rating Scale (NRS) score (0 = no pain;10 = worst imaginable pain; lower scores indicate better outcome)

    Measured: 1 - 4 days; 24 hours, 36 hours, 48 hours, 72 hours, 96 hours.

  3. Record of Participant Bowel Movement Patterns

    Onset of Bowel Movements - POD 1/POD 2/ POD 3/ > POD3

    Measured: 0 - 4 days; Whenever the patient experiences the bowel movement.

  4. Richmond Agitation Sedation Scale (RASS)

    Compare Richmond Agitation Sedation Scale (RASS) score at a different time point during the follow-up time. RASS score will be measured on a scale (from -5 = Unarousable to +4 = Combative where 0 = Alert and calm)

    Measured: 0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours.

  5. Patient Discomfort

    Patient Discomfort due to device (Yes / no)

    Measured: Time Frame: 0 - 4 days; Whenever the patient experiences the discomfort.

  6. Bleeding

    Bleeding at the site of device placement (Yes / No)

    Measured: Time Frame: 0 - 4 days; Whenever the patient experiences bleeding.

  7. Interference with Daily Activities

    Interference with activities of daily living due to the device (Yes/No)

    Measured: Time Frame: 0 - 4 days; Whenever the patient experiences disruption in daily activities.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start16 May 2023
  3. Primary completion13 Jan 2025
  4. Study completion13 Jan 2025

Resources

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, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05742711
Sponsor's protocol ID
CS015
Status last verified
Aug 2025
First submitted
2 Feb 2023
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arponrat P, Pongrojpaw D, Tanprasertkul C, Suwannarurk K, Bhamarapravatana K. Postoperative Pain Relief in Major Gynaecological Surgery by Perioperative Parecoxib Administration: Thammasat University Hospital Study. J Med Assoc Thai. 2015 Jul;98(7):636-42.

    PubMed 26267984

  • Pogatzki-Zahn E, Kutschar P, Nestler N, Osterbrink J. A Prospective Multicentre Study to Improve Postoperative Pain: Identification of Potentialities and Problems. PLoS One. 2015 Nov 24;10(11):e0143508. doi: 10.1371/journal.pone.0143508. eCollection 2015.

    PubMed 26600464

Questions about this trial

What is this clinical trial studying?

A study testing Primary Relief in people with Cancer of Endometrium and Cancer of Cervix, 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 5 Sep 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Rating Scale (NRS) (time frame: 0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours. Outcomes will be reported as an average over each individual postoperative day and as an average over 5 days independently for rest.). 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 NCT05742711, which also lists 2 linked publications.

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 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in