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Are reinfusion drains safe to use with periarticular liposomal bupivacaine? An analysis of systemic bupivacaine toxicity.

ABSTRACT: 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.

SUBMITTER: Angerame MR

PROVIDER: S-EPMC5994563 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Are reinfusion drains safe to use with periarticular liposomal bupivacaine? An analysis of systemic bupivacaine toxicity.

Angerame Marc R MR Hart Gavin P GP Odum Susan M SM Springer Bryan D BD

Arthroplasty today 20170831 2

<h4>Background</h4>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.<h4>Methods</h4>In this prospective study, ...[more]

PMID: 29896558

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Project description:ImportanceMore than half of patients who undergo knee replacement surgery report substantial acute postoperative pain.ObjectiveTo evaluate the efficacy and cost-effectiveness of periarticular liposomal bupivacaine for recovery and pain management after knee replacement.Design, setting, and participantsThis multicenter, patient-blinded, pragmatic, randomized clinical superiority trial involved 533 participants at 11 institutions within the National Health Service in England. Adults undergoing primary unilateral knee replacement for symptomatic end-stage osteoarthritis were enrolled between March 29, 2018, and February 29, 2020, and followed up for 1 year after surgery. Follow-up was completed March 1, 2021. A per-protocol analysis for each coprimary outcome was performed in addition to the main intention-to-treat analysis.InterventionsTwo hundred sixty-six milligrams of liposomal bupivacaine admixed with 100 mg of bupivacaine hydrochloride compared with 100 mg of bupivacaine hydrochloride alone (control) administered by periarticular injection at the time of surgery.Main outcome and measuresThe coprimary outcomes were Quality of Recovery 40 (QoR-40) score at 72 hours and pain visual analog scale (VAS) score area under the curve (AUC) from 6 to 72 hours. Secondary outcomes included QoR-40 and mean pain VAS at days 0 (evening of surgery), 1, 2, and 3; cumulative opioid consumption for 72 hours; functional outcomes and quality of life at 6 weeks, 6 months, and 1 year; and cost-effectiveness for 1 year. Adverse events and serious adverse events up to 12 months after randomization were also assessed.ResultsAmong the 533 participants included in the analysis, the mean (SD) age was 69.0 (9.7) years; 287 patients were women (53.8%) and 246 were men (46.2%). Baseline characteristics were balanced between study groups. There was no difference between the liposomal bupivacaine and control groups in QoR-40 score at 72 hours (adjusted mean difference, 0.54 [97.5% CI, -2.05 to 3.13]; P = .64) or the pain VAS score AUC at 6 to 72 hours (-21.5 [97.5% CI, -46.8 to 3.8]; P = .06). Analyses of pain VAS and QoR-40 scores demonstrated only 1 statistically significant difference, with the liposomal bupivacaine arm having lower pain scores the evening of surgery (adjusted difference -0.54 [97.5% CI, -1.07 to -0.02]; P = .02). No difference in cumulative opioid consumption and functional outcomes was detected. Liposomal bupivacaine was not cost-effective compared with the control treatment. No difference in adverse or serious adverse events was found between the liposomal bupivacaine and control groups.Conclusions and relevanceThis study found no difference in postoperative recovery or pain associated with the use of periarticular liposomal bupivacaine compared with bupivacaine hydrochloride alone in patients who underwent knee replacement surgery.Trial registrationisrctn.com Identifier: ISRCTN54191675.

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.

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.

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Are reinfusion drains safe to use with periarticular liposomal bupivacaine? An analysis of systemic bupivacaine toxicity.

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Are reinfusion drains safe to use with periarticular liposomal bupivacaine? An analysis of systemic bupivacaine toxicity.

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