Skip to main content
OpenTrials
Completed

NCT Number: NCT05742711

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer of Endometrium Cancer of Cervix Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Institute,(Wia)

Chennai, Tamil Nadu, 600020, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Primary Relief

Device

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

Other names: Percutaneous Electrical Nerve Stimulator (PENS)

Primary Relief - Sham Device

Device

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

Other names: Standard Treatment for Postoperative Pain

Primary outcomes

  1. 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.

    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)

Secondary outcomes

  1. Overall Postoperative analgesia and opioid requirement

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

    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.

  2. Patient Ambulation

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

    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)

  3. Record of Participant Bowel Movement Patterns

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

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

  4. Richmond Agitation Sedation Scale (RASS)

    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.

    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)

  5. Patient Discomfort

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

    Patient Discomfort due to device (Yes / no)

  6. Bleeding

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

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

  7. Interference with Daily Activities

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

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

Sponsors and collaborators

Lead sponsor

DyAnsys, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2023
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.