Emerging roles of liposomal bupivacaine in anesthesia practice.
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ABSTRACT:
SUBMITTER: Malik O
PROVIDER: S-EPMC5520585 | biostudies-other | 2017 Apr-Jun
REPOSITORIES: biostudies-other
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Project description:BACKGROUND:The relatively short duration of effect of local anesthetics has been addressed by encapsulation in drug delivery systems. Codelivery with a single compound that produces an adjuvant effect on nerve block but without intrinsic local anesthetic properties can further prolong the nerve block effect. Here, we investigated whether codelivery of more than 1 encapsulated adjuvant compound can further enhance nerve blockade. METHODS:Liposomes loaded with bupivacaine (Bup), dexamethasone phosphate (DexP), or dexmedetomidine (DMED) were synthesized and its in vitro drug release profiles were determined. Animals (Sprague-Dawley rats) were injected with liposomal Bup (Lipo-Bup) and adjuvants at the sciatic nerve and underwent a modified hot plate test to assess the degree of nerve block. The duration of block was monitored and the tissue reaction was assessed. RESULTS:Coinjection of Lipo-Bup with liposomal DexP (Lipo-DexP) and liposomal DMED (Lipo-DMED) prolonged the duration of sciatic nerve block 2.9-fold compared to Lipo-Bup alone (95% confidence interval, 1.9- to 3.9-fold). The duration of the block using this combination was significantly increased to 16.2 ± 3.5 hours compared to Lipo-Bup with a single liposomal adjuvant (8.7 ± 2.4 hours with Lipo-DMED, P = .006 and 9.9 ± 5.9 hours with Lipo-DexP, P = .008). The coinjection of Lipo-Bup with liposomal adjuvants decreased tissue inflammation (P = .014) but did not have a significant effect on myotoxicity when compared to Lipo-Bup alone. Coinjection of Lipo-Bup with unencapsulated adjuvants prolonged the duration of nerve block as well (25.0 ± 6.3 hours; P < .001) however was accompanied by systemic side effects. CONCLUSIONS:Codelivery of Lipo-DexP and Lipo-DMED enhanced the efficacy of Lipo-Bup. This benefit was also seen with codelivery of both adjuvant molecules in the unencapsulated state, but with marked systemic toxicity.
| S-EPMC5856594 | biostudies-literature
Project description:ObjectiveTo evaluate bupivacaine concentrations in maternal plasma and transfer into breast milk in women undergoing liposomal bupivacaine infiltration in the transversus abdominis plane after cesarean birth.MethodsProspective cohort study of healthy pregnant women who underwent cesarean birth at term followed by a transversus abdominis plane block using 52 mg bupivacaine hydrochloride 0.25% (20 mL) and 266 mg liposomal bupivacaine 1.3% (20 mL). Simultaneous blood and milk samples were collected in a staggered fashion, three to four samples per patient at the following timepoints after block administration: 2, 6, 12, 24, 48, 72, and 96 hours. Quantification of bupivacaine was performed by liquid chromatography-tandem mass spectrometry. Neonatal drug exposure was modeled by calculating milk/plasma area under the curve (AUC) ratios, neonatal dosage, and relative neonatal dosage of bupivacaine at each sampling time.ResultsThirty patients were enrolled. Concentrations in breast milk peaked at 6 hours (mean 58 ng/mL), followed by constant and steady decline to low levels at 96 hours (mean 5.2 ng/mL). Maternal plasma concentrations had two peaks, first at 6 hours (mean 155.9 ng/mL) and then at 48 hours (mean 225.8 ng/mL), followed by steady decline. Milk/plasma AUC0-t ratios ranged between AUC0-2 of 0.45 (80% CI 0.38-0.52) and AUC0-96 of 0.15 (80% CI 0.14-0.17). Neonatal dosage ranged between a mean of 355.9 ng/kg at 0-2 hours and a mean of 15,155.4 ng/kg at 0-96 hours. Relative neonatal dosage was less than 1% at all time intervals. No serious adverse reactions occurred in any neonate.ConclusionBupivacaine is excreted in breast milk after local infiltration of liposomal bupivacaine and bupivacaine hydrochloride mixture into transversus abdominis plane blocks after cesarean birth. Relative neonatal dosages of less than 1% (less than 10% is considered to be unlikely to be of clinical concern) suggest minimal risks for breastfeeding healthy, term neonates after the administration of this combination of local anesthetics to mothers.Clinical trial registrationClinicalTrials.gov, NCT03526419.
| S-EPMC7316148 | biostudies-literature
Project description:Background:The purpose of this study was to investigate if the addition of liposome bupivacaine (LB) to an interscalene block (ISB) had an effect on the number of patients with surgical- or block-related complications. Methods:This was a single-center retrospective chart view performed by identifying patients who received an ISB from January 1, 2014, through April 26, 2018, at the University of Minnesota. 1,518 patients were identified who received an ISB (LB?=?784, nonliposomal bupivacaine?=?734). Patients were divided into two groups those who did receive liposome bupivacaine in their ISB and those who did not receive liposome bupivacaine in their ISB. Medical records were individually reviewed for surgical procedure, block medications, complications related to the block or surgical procedure, phone calls to the healthcare system for issues related to opioids or pain within 3 and within 30 days, readmissions within 30 days, and emergency room visits for complications within 3 and 30 days. Results:There was no significant difference in the number of patients with surgical or anesthetic complications. Only phone calls for pain within 3 days were significantly different. The LB group had 3.2% of patients call compared to 5.6% in the nonliposomal bupivacaine group (aOR?=?1.71 (95% CI: 1.04-2.87), p=0.036). We found no significant difference in any of the other secondary outcomes. Conclusions:The use of LB in an ISB demonstrated no significant difference compared to nonliposomal bupivacaine in numbers of complications, emergency room visits, and readmissions.
| S-EPMC7139877 | biostudies-literature
Project description:The purpose of this study was to determine whether the use of a periarticular injection using liposomal bupivacaine could decrease pain and improve outcomes after total knee arthroplasty. Fifty consecutive patients received no periarticular injections (group A). Another 50 consecutive patients received a periarticular injection of liposomal bupivacaine (group B). There were no differences in the groups with respect to gender, age, body mass index (BMI), or comorbidities. There was a significant reduction in the amount of narcotics used in the liposomal bupivacaine group (60.97-mg oral morphine equivalent vs 89.74 mg, P = 0.009). Patients in group B with a BMI <40 and a Charlson comorbidity index of 0-3 had decreased length of stay (2.64 vs 3.06 days, P = .004), narcotic use over 24-48 hours (110.66 vs 182.47 mg, P = .013), and narcotic use over 48-72 hours (49.61 vs. 112.65 mg, P = .004). In patients with a BMI <40 and comorbidity index of ?3, periarticular injection using liposomal bupivacaine leads to earlier discharge along with decreased use of narcotics.
| S-EPMC4958110 | biostudies-literature
Project description:Background:Intraoperative periarticular injection (PAI) with local anesthetic is an important component of multimodal pain control in total joint arthroplasty (TJA). A potential risk of this practice is serum anesthetic toxicity resulting from the autotransfusion of blood collected from a reinfusion drain. The purpose of this study is to evaluate the levels of bupivacaine in blood collected in an autotransfusion system after use of a PAI in TJA. Methods:In this prospective study, each TJA patient had an identical PAI consisting of 20 cc of liposomal bupivacaine, 30 cc of 0.25% bupivacaine with epinephrine, and 10 cc of normal saline. An autologous reinfusion drain was utilized in all patients. At 2 and 5 hours postoperatively, blood was collected from the autotransfusion canister and sent to the laboratory to quantify bupivacaine levels. The sums of these levels were compared to the lowest reported serum bupivacaine dose associated with toxicity (1.1 mg/kg). Results:Eleven unilateral TJA patients were enrolled (6 total knee arthroplasties, 5 total hip arthroplasties). The average 2-hour serum bupivacaine level was 2.9 ?g (range 0.8-5.6) while the average 5-hour serum bupivacaine level was 4.5 ?g (range 0.4-10.0). The average sum of the 2-hour and 5-hour serum bupivacaine level was 5.6 ?g (range 0.8-13.6). Each of the 11 patient samples were well below their minimum serum bupivacaine dose toxicity. Conclusions:Use of a reinfusion drain after PAI with liposomal bupivacaine in TJA appears safe, as bupivacaine levels in the autotransfused blood remains well below the reported minimum serum toxic dose. Level of Evidence:IV.
| S-EPMC5994563 | biostudies-literature
Project description:BackgroundPeriarticular anesthesia (PAI) with liposomal bupivacaine (LB) and femoral nerve block (FNB) were 2 common type of pain management after total knee arthroplasty (TKA). There is no consensus about PAI with LB shows better clinical outcome than FNB. Thus, we performed a systematic review and meta-analysis to compare the efficacy and safety of PAI with LB and FNB for patients prepared for TKA.MethodsRandomized controlled trials (RCTs) and non-RCTs from PubMed (1966-2017.2), EMBASE (1980-2017.2), and the Cochrane Central Register of Controlled Trials (CENTRAL, 2017.2), Web of Science (1966-2017.2), and Chinese Wanfang database (1980-2017.2) were searched. Continuous outcomes including visual analogue scale (VAS) at 24, 48, and 72 hours, total morphine consumption, length of hospital, and range of motion (ROM) were reported as the weighted mean difference with 95% and confidence interval (CI) and discontinuous outcomes (the occurrence of postoperative nausea and vomiting [PONV]) were presented as relative risk with 95% CI. Random-effects model was adopted to analyze the relevant data.ResultsAccording to the inclusion and exclusion criteria, 8 studies with 2407 patients were eligible and finally included in this meta-analysis (LB = 1114, FNB = 1293). There was no significant difference between VAS at 24, 4, and 72 hours, ROM, and the occurrence of PONV between PAI with LB group versus FNB group (P > 0.05). Compared with the FNB group, PAI with LB was associated with a significant decrease in length of hospital stay by 0.43 day (MD = -0.43; 95% CI -0.60 to -0.27; P = 0.001) and the total dose of total morphine consumption by (MD = -29.32; 95% CI -57.55 to -1.09; P = 0.042).ConclusionsThe review of trials found that PAI with LB provided a significant beneficial effect over FNB in improving the pain or decreased the total morphine consumption in patients who underwent TKA. However, PAI with LB associated with less LOS than FNB. More high quality RCTs are still needed to identify the effects and optimal dose of LB for pain management after TKA.
| S-EPMC5380264 | biostudies-literature
Project description:The analgesic efficacy and safety of liposomal bupivacaine (LB) in third molar extraction was evaluated in this phase 3, double-blind, placebo-controlled study of subjects undergoing bilateral third molar extraction. Subjects were randomized 2 : 1 to infiltration with LB (133 mg/10 mL) or placebo, and received opioid rescue medication as needed. Primary efficacy measure was cumulative area under the curve (AUC) of numeric rating scale (NRS) pain severity scores through 48 hours (AUC of NRS0-48) postsurgery. Other measures included AUC of NRS0-24, AUC of NRS0-72, and AUC of NRS0-96, and incidence of adverse events. There were 150 subjects in the primary efficacy population (n = 99 LB, n = 51 placebo) and 89 in the per-protocol population (n = 59 LB, n = 30 placebo). Least-squares mean for AUC of NRS0-48 was 172.3 LB versus 194.7 placebo (P = .227) in the primary efficacy population and 120.8 LB versus 183.3 placebo (P = .023) in the per-protocol population. At all time points, between-group differences in AUC of NRS scores were significant in the per-protocol population (LB lower than placebo, P < .05) but not in the primary efficacy population. The adverse event profile was similar between groups. LB produced significantly lower cumulative pain scores versus placebo at all time points in the per-protocol analysis but not in the primary efficacy analysis because of protocol violations. This study indicates significant improvement in pain scores in the third molar model, but because of extensive protocol violations additional studies are warranted to demonstrate effectiveness.
| S-EPMC5579813 | biostudies-literature
Project description:Intrawound liposomal bupivacaine is a long-acting local anesthetic used to decrease postoperative pain in various procedures. Although it is used in posterior cervical and suboccipital approaches in the adult population, it is currently off-label for pediatrics. This quality improvement (QI) project examines intrawound liposomal bupivacaine for pediatric Chiari decompression and evaluates its role in postoperative opioid consumption.MethodsWe retrospectively analyzed all patients 0-18 years old of age who underwent Chiari decompression from January 2017 to July 2019 at our tertiary care hospital. Demographic and clinical data regarding postoperative opioid use, subjective and objective pain control, length of stay, discharge medications, and comorbid conditions were collected.ResultsWe included 30 patients in this study: 19 females and 11 males. Of these, 6 received an intrawound injection of liposomal bupivacaine.Patientstreated with liposomal bupivacaine require fewer opioids while admitted. There was no apparent difference in pain control immediately postoperatively, pain control at clinical follow-up, or inpatient length of stay between each group. Patients who received liposomal bupivacaine did not require opioid analgesics at the time of discharge from the hospital.ConclusionThe use of intrawound liposomal bupivacaine may decrease inpatient and outpatient postoperative opioid consumption amongst pediatric patients following Chiari decompression while providing adequate pain control. We investigate liposomal bupivacaine perioperative blockade in this QI project as a viable option for opioid-sparing pain control in the postoperative setting for the pediatric population. Future investigation via clinical trials and more extensive prospective studies may glean further insights into efficacy.
| S-EPMC8104281 | biostudies-literature
Project description:ObjectiveTo determine whether bupivacaine liposomal injectable suspension (BLIS) supports microbial growth when artificially inoculated and to evaluate liposomal stability in the face of this extrinsic contamination as evidenced by changes in free bupivacaine concentrations.Study designA randomized, prospective in vitro study in which three vials of each BLIS, bupivacaine 0.5%, and propofol were individually inoculated with known concentrations of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans (n = 36) to quantify bacterial and fungal growth was conducted. Over 120 hours, aliquots from contaminated vials were withdrawn, plated, and incubated to determine microbial concentrations. High-pressure liquid chromatography (HPLC) was used to evaluate free bupivacaine concentrations over time in BLIS. Data were analyzed using a mixed effects model with multiple comparisons.Sample populationTwelve vials of each BLIS, bupivacaine 0.5%, and propofol.ResultsBLIS did not support significant growth of Staphylococcus aureus or Candida albicans at any time. BLIS supported significant growth of Escherichia coli and Pseudomonas aeruginosa beginning at the 24 hour time point. Bupivacaine 0.5% did not support significant growth of any organisms. Propofol supported significant growth of all organisms. Free bupivacaine concentrations changed minimally over time.ConclusionBacterial and fungal contaminant growth in artificially inoculated BLIS is organism dependent. BLIS supports significant growth of Escherichia coli and Pseudomonas aeruginosa. Extra-label handling of BLIS should only be undertaken with caution and with adherence to strict aseptic technique.
| S-EPMC9934369 | biostudies-literature
Project description:Traditionally, opioids are heavily utilized in treating postoperative pain but they are associated with numerous side effects. The use of the transversus abdominis plane (TAP) blocks have become standard practice to extend the post-operative analgesic window and limit opioid use. A new liposomal-depo formulation of bupivacaine (Exparel) has gained popularity as a long-lasting TAP block medication, but has not been studied in a well-powered clinical trial specifically in colorectal patients nor compared to a bupivacaine/steroid mixture which may offer similar effects. We conduct a prospective randomized prospective randomized study of patients undergoing major laparoscopic colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus liposomal bupivacaine.
| 2288159 | ecrin-mdr-crc