- The patient is undergoing a routine (i.e., expected to be uncomplicated) total primary
or secondary hip replacement surgery performed under a standardized regimen of spinal
anesthesia, and is expected to experience moderate to severe post-surgical pain in the
absence of post-operative analgesia
- The patient is undergoing a revision to a previous hip replacement procedure, hip
replacement procedure further to a road traffic accident with multiple injuries, or a
procedure expected to last longer than 4 hours
- The patient has a history of uncontrolled chronic disease or a concurrent clinically
significant illness or medical condition, which in the Investigator's opinion, would
contraindicate study participation or confound interpretation of the results