CompletedNot Applicable

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

India48 participantsStarted 2023-05-16

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Numeric Rating Scale (NRS)

Timeframe: 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.

Trial details

NCT IDNCT05742711

SponsorDyAnsys, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-13