A study of the factors affecting the dose of the pain medication (fentanyl) used for treating pain after surgery in South Indian population.

Not Applicable

Completed

Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Registration Number: CTRI/2019/06/019588

Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 257

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

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).