title: The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study.
abstract: BACKGROUND
  Breast augmentation can result in significant postsurgical pain.
  
  
  OBJECTIVE
  The authors evaluate the extent and duration of analgesia achieved with extended-release DepoFoam bupivacaine (Pacira Pharmaceuticals, Inc., Parsippany, New Jersey) in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty under general anesthesia.
  
  
  METHODS
  In this randomized, multicenter, double-blind study, patients received a single dose of DepoFoam bupivacaine 600 mg or bupivacaine HCl 200 mg divided into the implant pockets at the conclusion of surgery. The primary efficacy measure was cumulative pain score with activity through 72 hours postoperatively. Secondary efficacy measures included pain intensity with activity and at rest, postsurgical consumption of rescue opioids, and integrated rank analysis combining pain scores at rest with the amount of opioid used.
  
  
  RESULTS
  One hundred thirty-six patients were randomized and treated (DepoFoam bupivacaine, n = 66; bupivacaine HCl, n = 70). Reflecting the underpowered nature of the study, the mean cumulative pain score (numeric rating scale with activity through 72 hours) was 441.5 with DepoFoam bupivacaine versus 468.2 with bupivacaine HCl (P = .3999). Total amounts of opioid consumed were significantly lower in the DepoFoam bupivacaine group through 24 hours (P = .0211) and through 48 hours (P = .0459). The prespecified integrated rank analysis showed statistically-significant differences at multiple time points up to and including 60 hours; results on most other efficacy measures trended in favor of DepoFoam bupivacaine. No serious adverse events were reported, and no patients discontinued the study due to adverse events.
  
  
  CONCLUSIONS
  DepoFoam bupivacaine trended toward benefit versus bupivacaine HCl on most efficacy measures. Due to early termination, the study was underpowered to achieve statistical significance.
authors.affiliation: Departments of Anesthesiology and Neurological Surgery,The Ohio State University, Columbus, Ohio, USA. johndsmoot@msn.com
authors.forename: John D
authors.initials: JD
authors.lastname: Smoot
authors.forename: Sergio D
authors.initials: SD
authors.lastname: Bergese
authors.forename: Erol
authors.initials: E
authors.lastname: Onel
authors.forename: Hayes T
authors.initials: HT
authors.lastname: Williams
authors.forename: William
authors.initials: W
authors.lastname: Hedden
mesh_terms: D000328:Adult; D000779:Anesthetics, Local / Q000008:administration & dosage*; D019540:Area Under Curve; D002045:Bupivacaine / Q000008:administration & dosage*; D003692:Delayed-Action Preparations / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016462:Mammaplasty / Q000379:methods*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000517:prevention & control*
chemical_list: D000779:Anesthetics, Local; D003692:Delayed-Action Preparations; D002045:Bupivacaine