Health Condition 1: C002- Malignant neoplasm of external lip, unspecified
Conditions
Interventions
Intervention1: Transdermal Buprenorphine Patch: Total Drug- 20 mg
Delivery Rate- 20 mcg/hr For 1st 48 hours Post operatively.
Control Intervention1: Intravenous Paracetamol: 15 mg/kg iv infusion over 15 min for 1st 48 hrs post operatively.
Sponsors
Arghya Maity
Eligibility
Inclusion criteria
Inclusion criteria: Patients belonging to either sex of age 18-65 years with ASA physical status I and II scheduled to undergo elective major plastic reconstructive surgery under GeneralAnaesthesia.
Exclusion criteria
Exclusion criteria: a) Patient refusal to give consent b) Patients with evidence of pre-existing pain in nonsurgical site (poly trauma, any fracture, neurological pain etc) c) Patients with significant cardiac, respiratory, hepatic or renal disorders or any other uncontrolled systemic illness d) Obesity(BMI >35) e) History of delirium tremens f) Pregnancy, Lactation g) History of allergy to Anaesthetic drugs and analgesics (Paracetamol, Diclofenac, Tramadol) and opioid addiction h) Those receiving long term analgesic therapy i) Infection and dermatitis at the site of patch application j) History of seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of Postoperative Pain by Visual Analogue Scale 2. Need of Rescue Analgesic 3. Degree of Postoperative Sedation by Ramsay Sedation ScaleTimepoint: Immediate Post operative period, at 2 hrs postoperatively, at 4 hrs postoperatively, at 12 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Haemodynamic changes ( Heart Rate, Non Invasive Blood Pressure - SBP/DBP/MAP , SpO2, ECG)Timepoint: Immediate Post operative period, at 2 hrs postoperatively, at 4 hrs postoperatively, at 12 hrs postoperatively, at 24 hrs postoperatively, at 36 hrs postoperatively, at 48 hrs postoperatively. | — |
Countries
India
Contacts
Public ContactArghya Maity
Institute of Post Graduate Medical Education and Research
Outcome results
None listed