Using PENS for pain relief after surgery in cancer patients
Efficacy of Percutaneous Electrical Neurostimulation (PENS)of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix
This study is testing if a device that uses tiny needles behind the ear can help relieve pain after surgery for cancer patients while reducing the need for opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | DyAnsys, Inc. Industry-sponsored |
| Locations | 1 site (Chennai, Tamil Nadu) |
| Trial ID | NCT05742711 on ClinicalTrials.gov |
What this trial studies
This interventional study investigates the efficacy of percutaneous electrical nerve stimulation (PENS) as a postoperative analgesic technique for patients undergoing surgery for cancer of the endometrium and cervix. The study aims to provide effective pain relief while minimizing the use of opioids and their associated side effects. Participants will receive PENS treatment, which involves the application of a device with tiny needles behind the ear to stimulate nerves and alter pain perception. The study is double-blinded to ensure unbiased results and will compare the PENS treatment to a sham device.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 diagnosed with stage I or II cancer of the endometrium or cervix who are scheduled for elective surgery.
Not a fit: Patients with advanced cancer stages, emergency surgeries, or those with a history of opioid dependence or chronic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid use and its side effects in postoperative cancer patients.
How similar studies have performed: While the use of PENS is a novel approach in this context, similar techniques have shown promise in other pain management studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chennai, Tamil Nadu
- Cancer Institute,(Wia) — Chennai, Tamil Nadu, India (Recruiting)
Study contacts
- Principal investigator: Dr. Sahithya Sriman, MBBS, MD — Cancer Institue, WIA,
- Study coordinator: Dr. Sahithya Sriman
- Email: sahithyaadhithyan@gmail.com
- Phone: +91-9840226923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.