Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 - 70 years. 2. Patients of female sex. 3. Patients of South Indian origin defined by history of belonging to any of the South Indian states, namely, Tamil Nadu, Kerala, Karnataka, Andhra Pradesh, Telangana and Pondicherry and having one of the South Indian languages as their mother tongue for 3 consecutive generations. 4. Patients undergoing major breast surgeries under general anaesthesia categorized as American Society of Anaesthesiology classification (ASA) I-III. (a measure of physical status of the patient). 5. Patients requiring postoperative intravenous fentanyl through Patient controlled Analgesia (PCA) pump.
Exclusion criteria
Exclusion criteria: 1. Pregnant patients and lactating mothers. 2. Patients with evidence of any Hepatic impairment (hepatic enzymes - SGOT or SGPT more than 3 times the upper limit of normal range) or Renal impairment (Creatinine clearance less than 90 ml/min as calculated by Cockroft - Gault equation). 3. Patients with continuous epidural analgesia in the postoperative period. 4. Patients on mechanical ventilation for more than 4 hours in the postoperative period. 5. Patients with peripheral neuropathy 6. Patients with localized skin lesions over the cubital fossa 7. Patients with history of any addiction to opioids or other narcotics. 8. Patients with history of use of any known inducers or inhibitors of CYP3A4 enzyme within 5 days of the study period (including alcohol, grape fruit juice, drugs like phenytoin, ketoconazole, etc).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between genetic markers and the total intravenous fentanyl dose for postoperative analgesiaTimepoint: 24 hours postoperative dose of fentanyl | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between genetic markers and cold pain toleranceTimepoint: preoperative period;Association between genetic markers and pupil response to intravenous fentanylTimepoint: 10 minutes after administering intravenous fentanyl for induction of anaesthesia;Association between genetic markers and the plasma norfentanyl/fentanyl ratioTimepoint: 30 minutes after administering intravenous fentanyl for induction of anaesthesia | — |
Countries
India
Contacts
Public ContactDr R Kesavan
Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)
Outcome results
None listed