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

Cancer of Cervix Clinical Trial

Official title:

Efficacy of Percutaneous Electrical Neurostimulation (PENS)of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742711
• Other study ID #: CS015
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: November 2024

Study information

• Verified date: June 2023
• Source: DyAnsys, Inc.
• Contact: Dr. Sahithya Sriman
• Phone: +91-9840226923
• Email: sahithyaadhithyan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Cervix
• Cancer of Endometrium
• Endometrial Neoplasms
• Uterine Cervical Neoplasms

Intervention

Device:
• Primary Relief
Continuous neurostimulation with a set of pre-assigned stimulation parameters.
• Primary Relief - Sham Device
Standard treatment with the application of sham device shall be followed with additional analgesics available if necessary.

Locations

Country	Name	City	State
India	Cancer Institute,(Wia)	Chennai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
DyAnsys, Inc.

Country where clinical trial is conducted

India, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS)	The primary goal is to evaluate the efficacy of PENS treatment in the change in postoperative pain after cancer surgery compared to the control group. The pain is measured using the numerical rating scale (NRS). Pain Score will be measured on a scale (0 = no pain;10 = worst imaginable pain; lower scores indicate better outcome)	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	Overall Postoperative analgesia and opioid requirement	To evaluate the effect of treatment in reducing the overall postoperative analgesia and opioid requirement. We will record the total dose and duration of additional analgesics required from the immediate postoperative period till pod 4 in iv morphine equivalents.	0 - 4 days, duration and dose of all prescriptions are recorded.
Secondary	Patient Ambulation	Evaluate the ease of patient ambulation by assessing associated Numeric Rating Scale (NRS) score (0 = no pain;10 = worst imaginable pain; lower scores indicate better outcome)	1 - 4 days; 24 hours, 36 hours, 48 hours, 72 hours, 96 hours.
Secondary	Record of Participant Bowel Movement Patterns	Onset of Bowel Movements - POD 1/POD 2/ POD 3/ > POD3	0 - 4 days; Whenever the patient experiences the bowel movement.
Secondary	Richmond Agitation Sedation Scale (RASS)	Compare Richmond Agitation Sedation Scale (RASS) score at a different time point during the follow-up time. RASS score will be measured on a scale (from -5 = Unarousable to +4 = Combative where 0 = Alert and calm)	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.
Secondary	Patient Discomfort	Patient Discomfort due to device (Yes / no)	Time Frame: 0 - 4 days; Whenever the patient experiences the discomfort.
Secondary	Bleeding	Bleeding at the site of device placement (Yes / No)	Time Frame: 0 - 4 days; Whenever the patient experiences bleeding.
Secondary	Interference with Daily Activities	Interference with activities of daily living due to the device (Yes/No)	Time Frame: 0 - 4 days; Whenever the patient experiences disruption in daily activities.

External Links

•   Pattern of use of analgesics in post-operative pain management in adults undergoing laparotomy surgery: a prospective observational study