TY - JOUR
T1 - Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy
T2 - A multicenter, randomized, double-blind, placebo-controlled trial
AU - Gorfine, Stephen R.
AU - Onel, Erol
AU - Patou, Gary
AU - Krivokapic, Zoran V.
PY - 2011/12
Y1 - 2011/12
N2 - BACKGROUND: Bupivacaine extended-release liposome injection is a novel formulation of bupivacaine designed to achieve long-acting postoperative analgesia. OBJECTIVE: The aim of this study was to compare the magnitude and duration of postoperative analgesia from a single dose of bupivacaine extended-release injection with placebo administered intraoperatively in patients undergoing hemorrhoidectomy. DESIGN: This evaluation was a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 study. SETTINGS: Data were obtained from 13 centers in the Republic of Georgia, Poland, and Serbia. PATIENTS: Included in this study were patients aged 18 to 86 years undergoing excisional hemorrhoidectomy. INTERVENTIONS: All patients received either a single dose of bupivacaine extended-release 300 mg or placebo administered intraoperatively via wound infiltration. MAIN OUTCOME MEASURE: The cumulative pain score was assessed by measurement of the area under the curve of pain intensity through 72 hours after study drug administration. RESULTS: One hundred eighty-nine patients were randomly assigned and treated; 186 completed the study. Pain intensity scores were significantly lower in the bupivacaine extended-release group in comparison with the group receiving placebo (141.8 vs 202.5, P <.0001). More patients in the bupivacaine extended-release group remained opioid free from 12 hours (59%) to 72 hours (28%) after surgery compared with patients receiving placebo (14% and 10%; P <.0008 through 72 h). The mean total amount of opioids consumed through 72 hours was 22.3 mg and 29.1 mg in the bupivacaine extended-release and placebo groups (P ≤.0006). The median time to first opioid use was 14.3 hours in the bupivacaine extendedrelease group vs 1.2 hours in the placebo group (P <.0001). A greater proportion of patients in the bupivacaine extended-release group were satisfied with their postsurgical analgesia (95% vs 73%, P=.0007) than in the placebo group. CONCLUSIONS: Bupivacaine extended-release demonstrated a statistically significant reduction in pain through 72 hours, decreased opioid requirements, delayed time to first opioid use, and improved patient satisfaction compared with placebo after hemorrhoidectomy.
AB - BACKGROUND: Bupivacaine extended-release liposome injection is a novel formulation of bupivacaine designed to achieve long-acting postoperative analgesia. OBJECTIVE: The aim of this study was to compare the magnitude and duration of postoperative analgesia from a single dose of bupivacaine extended-release injection with placebo administered intraoperatively in patients undergoing hemorrhoidectomy. DESIGN: This evaluation was a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 study. SETTINGS: Data were obtained from 13 centers in the Republic of Georgia, Poland, and Serbia. PATIENTS: Included in this study were patients aged 18 to 86 years undergoing excisional hemorrhoidectomy. INTERVENTIONS: All patients received either a single dose of bupivacaine extended-release 300 mg or placebo administered intraoperatively via wound infiltration. MAIN OUTCOME MEASURE: The cumulative pain score was assessed by measurement of the area under the curve of pain intensity through 72 hours after study drug administration. RESULTS: One hundred eighty-nine patients were randomly assigned and treated; 186 completed the study. Pain intensity scores were significantly lower in the bupivacaine extended-release group in comparison with the group receiving placebo (141.8 vs 202.5, P <.0001). More patients in the bupivacaine extended-release group remained opioid free from 12 hours (59%) to 72 hours (28%) after surgery compared with patients receiving placebo (14% and 10%; P <.0008 through 72 h). The mean total amount of opioids consumed through 72 hours was 22.3 mg and 29.1 mg in the bupivacaine extended-release and placebo groups (P ≤.0006). The median time to first opioid use was 14.3 hours in the bupivacaine extendedrelease group vs 1.2 hours in the placebo group (P <.0001). A greater proportion of patients in the bupivacaine extended-release group were satisfied with their postsurgical analgesia (95% vs 73%, P=.0007) than in the placebo group. CONCLUSIONS: Bupivacaine extended-release demonstrated a statistically significant reduction in pain through 72 hours, decreased opioid requirements, delayed time to first opioid use, and improved patient satisfaction compared with placebo after hemorrhoidectomy.
KW - Hemorrhoidectomy
KW - Liposomal bupivacaine
KW - Opioid sparing
KW - Patient satisfaction
KW - Postoperative pain
KW - Postsurgical pain
UR - http://www.scopus.com/inward/record.url?scp=84855162839&partnerID=8YFLogxK
U2 - 10.1097/DCR.0b013e318232d4c1
DO - 10.1097/DCR.0b013e318232d4c1
M3 - Article
C2 - 22067185
AN - SCOPUS:84855162839
SN - 0012-3706
VL - 54
SP - 1552
EP - 1559
JO - Diseases of the Colon and Rectum
JF - Diseases of the Colon and Rectum
IS - 12
ER -