NCT02480621 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Joshi GP, Cushner FD, Barrington JW, Lombardi AV Jr, Long WJ, Springer BD, Stulberg BN
Techniques for periarticular infiltration with liposomal bupivacaine for the management of pain after hip and knee arthroplasty: a consensus recommendation. J Surg Orthop Adv. 2015 Spring;24(1):27-35.
Lonner JH, Scuderi GR, Lieberman JR
Potential utility of liposome bupivacaine in orthopedic surgery. Am J Orthop (Belle Mead NJ). 2015 Mar;44(3):111-7. Review.
Owen RT
Bupivacaine liposome injectable suspension: a new approach to postsurgical pain. Drugs Today (Barc). 2013 Aug;49(8):475-82. doi: 10.1358/dot.2013.49.8.2006992.
Robbins J, Green CL, Parekh SG
Liposomal bupivacaine in forefoot surgery. Foot Ankle Int. 2015 May;36(5):503-7. doi: 10.1177/1071100714568664. Epub 2015 Jan 22.

The Impact of Liposomal Bupivicaine on Post-Operative Pain in Orthopaedic Trauma Surgery: A Double-Blind Prospective Randomized Control Trial

Clinical trial NCT02480621 - References