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

DyAnsys

Status: Completed

Conditions: Cancer of Endometrium; Cancer of Cervix

Treatments: Device: Primary Relief; Device: Primary Relief - Sham Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05742711

CS015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Treatment Group

Experimental group

Description:

The group who have received PENS treatment using PrimaryRelief in addition to Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS\>4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain.

Treatment:

Device: Primary Relief

Control Group

Sham Comparator group

Description:

The group who have received a sham device along with Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS\>4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain.

Treatment:

Device: Primary Relief - Sham Device