TWO PHASE III STUDIES IN OPEN INGUINAL HERNIOPLASTY
Two Phase III studies of identical design were performed as outpatient surgeries in adults across 39 sites in the US1
- PRIMARY ENDPOINT: Time-weighted sum of pain intensity from 0 through 24 hours‡
- SECONDARY ENDPOINT: Total use of opioid analgesia (TOpA)
- *Doses above 300 mg per patient have not been studied in clinical trials.
- †Intravenous morphine provided until patients were able to tolerate oral morphine.
- ‡Sum of Pain Intensity is an FDA-accepted measurement of pain, calculated by using patient ratings of pain intensity on a 0-10 scale reported at multiple points from baseline over a time period.3