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

INTERVENTION: Intervention1: Study group: Once adequate NPO has been confirmed, under routine ASA guideline monitoring the patients are premedicated with fentanyl in a dosage of 1.5ug/kg followed by induction with propofol 1.5‐2.5mg/kg and paralysed with vecuronium 0.1mg/kg. Following tracheal intubation anaesthesia will be maintained using an oxygen:nitrous oxide mixture combined with an inhalant. Analgesia with injection paracetamol at a dosage of 15mg/kg to be administered prior to incision placement. Supplementation with (short acting opioids) fentanyl at 0.5ug/kg for every hour from the time of induction based on hemodynamic parameters (i.e 20% increase from baseline heart rate and BP) with repeat doses if deemed necessary. Patients will have a working PENS device under trade name of Primary Relief placed as per manufacturerâ??s protocol two hours priors to the estimated time of extubation and placement will be done by a clinician blinded to the study. The mode of functioning would be continuous neurostimulation of 1‐100 Hz frequency sweep. Assessment of pain scores will start in the immediate post‐operative period after extubation. Postoperative analgesic regimen will be Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS more than 4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain. Pain scores and analgesic requirements will be monitored up till pod 4. Device will be removed on POD 4 Control Intervention1: Control group: Once adequate NPO has been confirmed, under routine ASA guideline monitoring the patients are premedicated with fentanyl in a dosage of 1.5ug/kg followed by induction with propofol 1.5‐2.5mg/kg and paralysed with vecuronium 0.1mg/kg. Following tracheal intubat CONDITION: Health Condition 1: C539‐ Malignant neoplasm of cervi Xuteri, unspecified Health Condition 2: C541‐ Malignant neoplasm of endometrium PRIMARY OUTCOME: 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: Postoperative: ; Reduction in opioid consumption ; Ease of patient ambulation/spirometry ; Onset of bowel movements ; Sedation scores ; PENS device tolerabilityTimepoint: Post operative days 0‐4 ; 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 ; NRS associated with mobility/ spirometry from POD 1‐4 INCLUSION CRITERIA: Diagnosed with CA‐endometrium OR CA ‐cervi Xof stage I/II and post RT CA cervi Xpatients coming for hysterectomy Elective surgery Informed consent obtained ASA (American Society of Anaesthesiology) physical status 1‐3