Clinical trial NCT05742711: Efficacy of PENS of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix Patients
Official title: Efficacy of Percutaneous Electrical Neurostimulation (PENS)of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer of Endometrium
Cancer of Cervix
Lead sponsor: DyAnsys, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: 0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours. Outcomes will be reported as an average over each individual postoperative day and as an average over 5 days independently for rest.
Secondary outcomes:
measure: Overall Postoperative analgesia and opioid requirement
timeFrame: 0 - 4 days, duration and dose of all prescriptions are recorded.
measure: Patient Ambulation
timeFrame: 1 - 4 days; 24 hours, 36 hours, 48 hours, 72 hours, 96 hours.
measure: Record of Participant Bowel Movement Patterns
timeFrame: 0 - 4 days; Whenever the patient experiences the bowel movement.
measure: Richmond Agitation Sedation Scale (RASS)
timeFrame: 0 - 4 days; 0 hours, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours.
measure: Patient Discomfort
timeFrame: Time Frame: 0 - 4 days; Whenever the patient experiences the discomfort.
measure: Bleeding
timeFrame: Time Frame: 0 - 4 days; Whenever the patient experiences bleeding.
measure: Interference with Daily Activities
timeFrame: Time Frame: 0 - 4 days; Whenever the patient experiences disruption in daily activities.
Other outcomes:
Locations:
city: Chennai
country: India
facility: Cancer Institute,(Wia)
state: Tamil Nadu
Study officials:
affiliation: Cancer Institue, WIA,
name: Dr. Sahithya Sriman, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arponrat P, Pongrojpaw D, Tanprasertkul C, Suwannarurk K, Bhamarapravatana K. Postoperative Pain Relief in Major Gynaecological Surgery by Perioperative Parecoxib Administration: Thammasat University Hospital Study. J Med Assoc Thai. 2015 Jul;98(7):636-42.
citation: Pogatzki-Zahn E, Kutschar P, Nestler N, Osterbrink J. A Prospective Multicentre Study to Improve Postoperative Pain: Identification of Potentialities and Problems. PLoS One. 2015 Nov 24;10(11):e0143508. doi: 10.1371/journal.pone.0143508. eCollection 2015.