A clinical trial to assess the ability of â€œPENS"- a medical device, in reducing pain levels after surgery in patients with cancer of cervix or endometrium

Phase 3

Not yet recruiting

Conditions: Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: C541||Malignant neoplasm of endometrium,

Registration Number: CTRI/2023/03/050432

Lead Sponsor: Dr Sahithya Sriman

Brief Summary: This study aims to test the efficacy of PENS device (-a minimally invasive neurostimulation device which acts by stimulating the nerves around the auricle percutaneously) in decreasing pain scores in cancer endometrium / cervix patients after their elective laparotomy surgeries as the primary outcome.

Adequate post operative pain relief through PENS device will help reduce the amount of opioid (the most commonly used analgesic agent) consumed in the post operative period and hence their associated side effects. The study will also analyse for improvements in other recovery parameters such as mobility, bowel movements, sedation scores, ease/ patient comfort with PENS device and these are translated as secondary outcomes

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 48

Inclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in postoperative pain scores as measured by NRS pain scale between 0-10	POD 0-4 Postoperative hours 0-hrs, 2-hrs, 4-hrs, 8-hrs,12-hrs, 18-hrs, 24-hrs, 36-hrs, 48-hrs, 72-hrs, 96-hrs

Secondary Outcome Measures

Name	Time	Method
Postoperative:	Reduction in opioid consumption

Trial Locations

Locations (1): Cancer Institute (WIA)
🇮🇳
Chennai, TAMIL NADU, India
Cancer Institute (WIA)
🇮🇳Chennai, TAMIL NADU, India
Dr Sahithya Sriman
Principal investigator
9840226923
sahithyaadhithyan@gmail.com