A Phase II trial of a single intraoperative administration of Exparel (DepoBupivacaine) resulted in significantly reduced pain with activity in the first 8 to 24 hours following surgery, when pain is generally greatest, compared to conventional treatment.
The results of the multicenter, randomized, double-blind study were presented in a poster at the Annual Postgraduate Assembly in Anesthesiology in New York City today, by lead investigator Richard Langford, MD, FRCA, Pain and Anaesthesia Research Centre, St. Bartholomew's Hospital, London, UK.
Dr. Langford indicated that Exparel provided safe and well-tolerated analgesia with normal wound healing in all patients and noted that the study also showed:
- Significant reductions in pain with activity in Exparel treated patients compared to active control
- A positive trend toward lower opioid use in all Exparel groups compared to active control
- More patients who received Exparel avoided opioids altogether, compared to active control.
In addition, the study demonstrated dose-proportional sustained plasma concentrations which support the prolonged local release of bupivacaine.
Presenting the results, Dr. Langford stated, "In addition to significantly lowering pain scores with activity during the 8 to 24 hours after administration, Exparel also showed trends of decrease in the number of patients using opioids and a decrease in total opioid consumption. This is an important finding as lowering opioid usage can spare patients from side effects, such as sedation, nausea, vomiting and respiratory depression, that can adversely affect their recovery."
Exparel, a proprietary product of Pacira Pharmaceuticals, Inc., is a novel long-acting, sustained-release formulation of bupivacaine HCL, a local anesthetic widely used for treating postoperative pain. The dose-escalating study evaluated the efficacy, safety, and pharmacokinetics of Exparel compared to bupivacaine HCL in 76 adult male patients (age ranges 48 to 63) in 10 hospitals in the UK and Australia. Subjects were randomized into one of four cohorts and intraoperatively administered either 175mg, 225mg, 300mg or 325mg of Exparel or 100mg bupivacaine HCL around the surgical wound by infiltration immediately before closure.