The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study.

BACKGROUND: Breast augmentation can result in significant postsurgical pain. OBJECTIVES: 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.

Retrospective review of the internal Doppler probe for intra- and postoperative microvascular surveillance.

The purpose of this review was to evaluate the utility of the 20 MHz microvascular implantable Doppler probe for free-tissue transfer, both intra- and postoperatively. Over a 15-month period, the Doppler probe was used in a total of 260 anastomoses, including 118 arterial and 142 venous microanastamoses. In these 260 anastomoses, there were six false positive results and eight true positives, resulting in one flap loss. The free flap success rate was 99 percent, the re-exploration rate was 8 percent, and the salvage rate was 83 percent. The internal Doppler offers an easy and reliable way to monitor microvascular free-tissue transfer both intra- and postoperatively. This study demonstrates the continued increase in survival, as well as salvage, of free-tissue transfer.