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

NCT05742711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-05

No results posted yet for this study

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. 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.

Conditions

  • Cancer of Endometrium
  • Cancer of Cervix

Interventions

DEVICE

Primary Relief

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

DEVICE

Primary Relief - Sham Device

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

Sponsors & Collaborators

  • DyAnsys, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Sahithya Sriman, MBBS, MD · Cancer Institue, WIA,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2025-01-13
Completion
2025-01-13

Countries

  • India

Study Locations

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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 NCT05742711 on ClinicalTrials.gov