Health Condition 1: null- Having breast cancer, posted for modified radical mastectomy Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Pregabalin: 75 mg pregabalin capsules, To be started two hours before sugery on the morning of surgery. given as B.D dose till one week after surgery.
Control Intervention1: placebo cap
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1. American society of anesthesiologistâ??s (ASA) physical status (PS) I and II 2. Age 18-65 years. 3. BMI 4. Patients undergoing modified radical mastectomy.
Exclusion criteria
Exclusion criteria: 1. Refusal to participate in study, 2. Known allergy to any of the anaesthetic drugs used, 3. History of drug or alcohol abuse, 4. Patients with impaired kidney or liver functions, 5. Patients with chronic pain or regularly receiving analgesics, 6. Previous or current use of gabapentinoids 7. Patient on antianxiety drugs, or antianxiety drugs given preoperatively 8. History of epilepsy 9. Bilateral mastectomy 10. History of previous breast surgery ( excluding diagnostic biopsy) 11. Cancer recurrence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the impact of oral pregabalin on incidence of chronic post mastectomy pain syndromeTimepoint: 3 months post operative. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess effect of pregabalin on pain at one month after surgery. Asses effect of pregabalin on acute post-operative pain and analgesic requirements. Assess adverse effects due to pregablin.( sedation, dizziness) Timepoint: 1 month post operatively, 1,2,6,12,24 and 48 hours after surgery. | — |
Countries
India
Contacts
Public ContactDr Saurabh Vig
A.I.I.M.S New Delhi.
Outcome results
None listed