A clinical trial to assess the ability of â??PENS"- a medical device, in reducing pain levels after surgery in patients with cancer of cervix or endometrium

EFFICACY OF PERCUTANEOUS ELECTRICAL NEUROSTIMUATION (PENS) OF THE AURICLE AS AN OPIOID SPARING POSTOPERATIVE ANALGESIC TECHNIQUE IN CANCER ENDOMETRIUM AND CANCER CERVIX PATIENTS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050432

Enrollment

Registered

2023-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 2: C541- Malignant neoplasm of endometrium

Interventions

Intervention1: Study group: Once adequate NPO has been confirmed, under routine ASA guideline monitoring the patients are premedicated with fentanyl in a dosage of 1.5ug/kg followed by induction with

Eligibility

Inclusion criteria

Inclusion criteria: 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

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

Design outcomes

Primary

Measure	Time frame
Reduction in postoperative pain scores as measured by NRS pain scale between 0-10Timepoint: POD 0-4 Postoperative hours 0-hrs, 2-hrs, 4-hrs, 8-hrs,12-hrs, 18-hrs, 24-hrs, 36-hrs, 48-hrs, 72-hrs, 96-hrs	—

Secondary

Measure	Time frame
Postoperative: Reduction in opioid consumption Ease of patient ambulation/spirometry Onset of bowel movements Sedation scores PENS device tolerabilityTimepoint: Post operative days 0-4 Sedation scale at postoperative hours 0-hrs, 2-hrs, 4-hrs, 8-hrs,12-hrs, 18-hrs, 24-hrs, 36-hrs, 48-hrs, 72-hrs, 96-hrs NRS associated with mobility/ spirometry from POD 1-4	—

Countries

India

Contacts

Public ContactDr Sahithya Sriman

Cancer Institute (WIA)

sahithyaadhithyan@gmail.com9840226923

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026