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

Launched by DYANSYS, INC. · Feb 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new technique called PENS (Percutaneous Electrical Nerve Stimulation) applied to the ear to help manage pain after surgery for patients with certain types of cancer, specifically cancer of the endometrium (the lining of the uterus) and cancer of the cervix. The goal is to provide effective pain relief while reducing the need for opioids, which can have unwanted side effects. The researchers believe that this method could lead to better pain management with fewer complications.

To be eligible for this trial, participants need to be women aged 18 or older who have been diagnosed with stage I or II endometrial or cervical cancer and are scheduled for elective surgery. They should also be in good general health, as determined by their anesthesiologist. Participants will receive the PENS treatment and will be monitored for pain relief and any side effects. It's important to note that some individuals, such as those with certain medical conditions or who are currently using opioids, may not qualify for the study. If you are interested in learning more or considering participation, please discuss it with your healthcare provider.

Gender

FEMALE

Eligibility 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