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

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

NCT ID: NCT05742711

Condition: Cancer of Endometrium
Cancer of Cervix

Conditions: Official terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Primary Relief
Description: Continuous neurostimulation with a set of pre-assigned stimulation parameters.
Arm group label: Treatment Group

Other name: Percutaneous Electrical Nerve Stimulator (PENS)

Intervention type: Device
Intervention name: Primary Relief - Sham Device
Description: Standard treatment with the application of sham device shall be followed with additional analgesics available if necessary.
Arm group label: Control Group

Other name: Standard Treatment for Postoperative Pain

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.

Detailed description: Efficient post operative pain relief is an essential part of comprehensive recovery of patients. Conventional method of pain management of laparotomy surgeries in CA endometrium and cervix patients involves invasive techniques like epidural or selective nerve block coupled with a varied choice of analgesics like opioids, NSAID or acetaminophen, wherein each drug is associated with its own set of contraindications and side effects. Despite advances in analgesic regimen including multimodal analgesic regimen, opioids have been observed to remain the mainstay postoperative analgesia in cancer patients despite its well-established side effects. This double-blinded prospective interventional study is conducted to explore the alternative of percutaneous electrical nerve stimulation (PENS) devices for effective pain relief with minimal to no side-effects. The device will have tiny needles and a battery system that will be placed on and behind the patient's ear when they are under anesthesia. It acts by stimulating nerves around ear region by series of pain free impulse generation leading to centrally (brain) mediated response by altering certain chemical substances responsible for causing pain thereby providing relief for the patient.

Criteria for 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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Institute,(Wia)

Address:
City: Chennai
Zip: 600020
Country: India

Status: Recruiting

Contact:
Last name: Dr. Sahithya Sriman,, MBBS, MD

Phone: +91-9840226923
Email: sahithyaadhithyan@gmail.com

Start date: May 16, 2023

Completion date: November 28, 2024

Lead sponsor:
Agency: DyAnsys, Inc.
Agency class: Industry

Source: DyAnsys, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05742711
https://www.ijsurgery.com/index.php/isj/article/view/2388