2012
DOI: 10.1177/1090820x11430831
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The Efficacy and Safety of DepoFoam Bupivacaine in Patients Undergoing Bilateral, Cosmetic, Submuscular Augmentation Mammaplasty: A Randomized, Double-Blind, Active-Control Study

Abstract: DepoFoam bupivacaine trended toward benefit versus bupivacaine HCl on most efficacy measures. Due to early termination, the study was underpowered to achieve statistical significance.

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Cited by 103 publications
(71 citation statements)
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“…The development of a depot formulation of bupivacaine attempts to address this issue, as a liposomal formulation allows for the slow release of the local anesthetic over a period measured in days and not hours [67][68][69]. Although non-randomized, retrospective, unmasked studies have reported dramatic benefits of using liposome bupivacaine infiltration versus both a bupivacaine infusion or no local anesthetic involvement-such as decreasing hospitalization duration and pain scores 40-50% up to 24 hours postoperatively [70]-two randomized, bupivacaine HCl-controlled trials failed to detect any benefits apart from decreased opioid consumption through 48-60 hours [71,72]. Considering the lack of RCT-demonstrated benefits of liposome bupivacaine versus bupivacaine HCl combined with the 100-fold increase in cost of the former over the latter, it appears that additional data demonstrating analgesic or other benefits is warranted prior to widespread adoption of the new formulation.…”
Section: Liposome Bupivacainementioning
confidence: 99%
“…The development of a depot formulation of bupivacaine attempts to address this issue, as a liposomal formulation allows for the slow release of the local anesthetic over a period measured in days and not hours [67][68][69]. Although non-randomized, retrospective, unmasked studies have reported dramatic benefits of using liposome bupivacaine infiltration versus both a bupivacaine infusion or no local anesthetic involvement-such as decreasing hospitalization duration and pain scores 40-50% up to 24 hours postoperatively [70]-two randomized, bupivacaine HCl-controlled trials failed to detect any benefits apart from decreased opioid consumption through 48-60 hours [71,72]. Considering the lack of RCT-demonstrated benefits of liposome bupivacaine versus bupivacaine HCl combined with the 100-fold increase in cost of the former over the latter, it appears that additional data demonstrating analgesic or other benefits is warranted prior to widespread adoption of the new formulation.…”
Section: Liposome Bupivacainementioning
confidence: 99%
“…The structure of liposome bupivacaine allows for drug release over several days after administration into the surgical site 14,15 . In published prospective clinical studies in patients undergoing total knee arthroplasty 16 , hemorrhoidectomy 17,18 , breast augmentation 19 , or bunionectomy 20 , a single administration of liposome bupivacaine at the surgical site was well tolerated and associated with lower mean cumulative pain scores, comparable or less opioid consumption, and a comparable adverse event profile compared with bupivacaine HCl or placebo.…”
Section: Introductionmentioning
confidence: 97%
“…[15][16][17][18] However, its role in managing postoperative pain in patients undergoing spine surgery is not well understood. Due to the paucity of literature on this topic, the primary goal of this study is to determine the efficacy of LB following posterior lumbar decompression and fusion (PLDF) in a prospective, randomized placebo-controlled trial.…”
mentioning
confidence: 99%