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.
OBJECTIVESTo investigate the effect of lower urinary tract symptoms (LUTS) on quality of life (QoL) and to determine its extent across a variety of cultures, and the confounding effects of self-reported comorbidities and demographics.
SUBJECTS AND METHODSData were obtained from two populationbased studies in five cities: UREPIK (Boxmeer, the Netherlands; Auxerre, France; Birmingham, UK; and Seoul, Korea) and the Boston Area Community Health (BACH) study (Boston, USA). UREPIK used stratified random samples of men aged 40-79 years. BACH used a multistage stratified cluster sample to randomly select adults aged 40-79 years. QoL was assessed using a standard Medical Outcomes Study-Short Form 12 (SF-12, mental and physical health component scores); LUTS was assessed using the International Prostate Symptom Score (IPSS). The association between QoL and IPSS, associated illnesses, and lifestyle factors was investigated using weighted regression.
RESULTSThe UREPIK studied 4800 men aged 40-79 years; BACH recruited 1686 men aged 40-79 years. The prevalence of LUTS, defined as an IPSS of ≥ 8, varied by city ( P < 0.001), with Auxerre reporting a prevalence ( SE ) of 18.1 (1.2)%, Birmingham 25.6 (1.5)%, Boston 25.1 (1.6)%, Boxmeer 21.2 (1.3)%, and Seoul 19.0 (1.2)%. Overall, this was similar to the In a large epidemiological study, authors investigated the effect of LUTS on quality of life among various cultures. They showed a close association between the two, and that the effect of having moderate symptoms has a similar effect on quality of life as diabetes, hypertension or cancer, and that having severe symptoms had a similar effect as a heart attack or stroke.
Local anaesthetics are often used as part of multimodal pain management techniques to manage postsurgical pain and lessen the need for opioid analgesics; however, the duration of action of traditional formulations of local anaesthetics is short. Liposome bupivacaine is a novel, multivesicular formulation designed for rapid absorption, prolonged release of bupivacaine, and analgesia following a single intra-operative administration into the surgical wound. This article provides a summary of the pharmacokinetic profile of liposome bupivacaine compared with bupivacaine HCl based on data compiled from four randomized, active- and placebo-controlled trials that included pharmacokinetic assessments following single administrations of study drug. Each study evaluated the safety, efficacy and pharmacokinetic profile of liposome bupivacaine in separate surgical populations (patients undergoing inguinal hernia repair, total knee arthroplasty, haemorrhoidectomy or bunionectomy). Pharmacokinetic parameters included maximum plasma drug concentration (C(max)), area under the curve (AUC) for plasma bupivacaine concentration over time extrapolated to infinity (AUC(∞)), time to observed C(max) (t(max)) and terminal elimination half-life of bupivacaine (t(½)). The studies assessed single administrations of liposome bupivacaine at dose levels ranging from 106 to 532 mg or bupivacaine HCl 100 to 150 mg or placebo (0.9 % sodium chloride) given locally via wound infiltration at the end of surgery prior to wound closure. Male and non-pregnant female patients (n = 253) aged ≥18 years, scheduled to undergo surgery as per the specific protocol for each study, were enrolled. Patient characteristics were stratified by liposome bupivacaine doses ≤266 mg and >266 mg, and bupivacaine HCl treatment arms. Pharmacokinetic parameters for liposome bupivacaine doses of 106, 266, 399 and 532 mg were compared. Plasma concentration versus time profiles were quantitatively similar across these four dose levels of liposome bupivacaine, with an initial peak occurring within 1 h after administration followed by a second peak about 12-36 h later. The overall incidence of adverse events was lower in the liposome bupivacaine ≤266-mg group than the liposome bupivacaine >266-mg and bupivacaine HCl groups (100- or 150-mg doses). In summary, liposome bupivacaine was well tolerated across the four studies and varied surgical models, and exhibited bimodal kinetics with rapid uptake observed during the first few hours and prolonged release through 96 h after administration.
This randomized, active-controlled study evaluated the extent and duration of analgesia after administration of liposome bupivacaine (LB), a novel formulation of bupivacaine, compared with bupivacaine HCl given via local infiltration in excisional hemorrhoidectomy. One hundred patients were randomly assigned to receive a single dose of bupivacaine HCl 75 mg (0.25% with 1:200,000 epinephrine) or LB 66, 199, or 266 mg upon completion of hemorrhoidectomy. Postoperative pain intensity was assessed using a numeric rating scale at rest to calculate a cumulative pain score (area under the curve). Cumulative pain scores were significantly lower with LB at each study dose ( P < 0.05) compared with bupivacaine HCl 72 hours after surgery. Post hoc analysis showed that mean total postoperative opioid consumption was statistically significantly lower for the LB 266-mg group compared with the bupivacaine HCl group during the 12- to 72-hour postoperative period ( P = 0.019). Median time to first opioid use was 19 hours for LB 266 mg versus 8 hours for bupivacaine HCl ( P = 0.005). Incidence of opioid-related adverse events was 4 per cent for LB 266 mg compared with 35 per cent for bupivacaine HCl ( P = 0.007). Local infiltration with LB resulted in significantly reduced postsurgical pain compared with bupivacaine HCl in patients after hemorrhoidectomy surgery.
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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