A clinical trial to assess the ability of â??PENS- a medical device, in reducing pain levels after surgery in patients with cancer of cervix or endometrium
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecifiedHealth Condition 2: C541- Malignant neoplasm of endometrium
- Registration Number
- CTRI/2023/03/050432
- Lead Sponsor
- Dr Sahithya Sriman
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 0-10Timepoint: 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: <br/ ><br>Reduction in opioid consumption <br/ ><br>Ease of patient ambulation/spirometry <br/ ><br>Onset of bowel movements <br/ ><br>Sedation scores <br/ ><br>PENS device tolerabilityTimepoint: Post operative days 0-4 <br/ ><br>Sedation scale at postoperative hours 0-hrs, 2-hrs, 4-hrs, 8-hrs,12-hrs, 18-hrs, 24-hrs, 36-hrs, 48-hrs, 72-hrs, 96-hrs <br/ ><br>NRS associated with mobility/ spirometry from POD 1-4