Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study

DeClaire, Jeffrey H.; Aiello, Paige; Warritay, Olayinka K.; Freeman, D. Carl

doi:10.1016/j.arth.2017.03.062

Cited by 38 publications

(26 citation statements)

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“…2). [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] Four studies 7,13,15,18 compared other groups in addition to liposomal bupivacaine and traditional PAI, so we selected only the data related to liposomal bupivacaine and traditional PAI for analysis. Finally, nine RCTs and seven nRCTs were included in our review (►Table 1).…”

Section: Study Selectionmentioning

confidence: 99%

“…The drugs used for PAI included ropivacaine or bupivacaine, epinephrine, and one type of opiate such as morphine. Ten studies 8,11,[13][14][15][16][17]19,20,22 used ropivacaine, six studies 7,9,10,14,18,21 used bupivacaine, and one study 12 used one of them (►Table 1). Notably, 10 studies 7-9,15,17-22 reported one or more of their authors have disclosed potential or pertinent con-flicts of interest, and almost all these studies were RCTs except one.…”

Section: Study Characteristics and Qualitymentioning

confidence: 99%

“…25,26 Several independent studies comparing liposomal bupivacaine and traditional PAI for pain control after TKA have been reported in recent years. [18][19][20]22 Although some reviews or meta-analyses of these studies have previously been performed, 27,28 newer studies have become available in the literature in recent years. Therefore, we performed a meta-analysis including additional trials and a greater caseload to evaluate the clinical outcomes of liposomal bupivacaine and traditional PAI for postoperative pain control after TKA.…”

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confidence: 99%

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A Meta-Analysis Comparing Liposomal Bupivacaine and Traditional Periarticular Injection for Pain Control after Total Knee Arthroplasty

et al. 2018

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Liposomal bupivacaine is a novel method for pain control after total knee arthroplasty (TKA), but recent studies showed no advantage for patients undergoing TKA compared with traditional periarticular injection (PAI). The purpose of this analysis was to compare the clinical outcomes between liposomal bupivacaine treatment and traditional PAI. We retrospectively reviewed data from 16 clinical trials in published databases from their inception to June 2017. The primary outcome was postoperative Visual Analogue Scale (VAS) score and secondary outcomes included opiate usage, narcotic consumption, range of motion, and length of stay. Nine randomized controlled trials and seven nonrandomized controlled trials involving 924 liposomal bupivacaine cases and 1,293 traditional PAI cases were eligible for inclusion in the meta-analysis. No differences were detected in most of the clinical outcomes, except for postoperative VAS within 12 hours and length of stay. This analysis showed that liposomal bupivacaine is not associated with significant improvement in postoperative pain control or other outcomes in TKA compared with PAI.

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Section: Study Selectionmentioning

confidence: 99%

Section: Study Characteristics and Qualitymentioning

confidence: 99%

mentioning

confidence: 99%

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A Meta-Analysis Comparing Liposomal Bupivacaine and Traditional Periarticular Injection for Pain Control after Total Knee Arthroplasty

et al. 2018

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“…The diligence and consistency in our multimodal pain cocktail, which was matched between groups, leaves little room for procedure bias or confounding when all drugs and dosages are held constant apart from the drug that is studied. The use of multimodal pain management in orthopedic surgery has been validated by the Journal of Clinical Anesthesia as Dr Jin explains that "multimodal analgesia should be a routine practice to control postoperative pain in inpatients" [1].…”

Section: To the Editormentioning

confidence: 99%

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Letter to the Editor on “Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study”

Dysart

Dagenais

2018

The Journal of Arthroplasty

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We read with great interest the recent study by DeClaire et al [1] on liposomal bupivacaine (LB; EXPAREL, bupivacaine liposome injectable suspension; Pacira Pharmaceuticals, Inc, Parsippany, NJ) for total knee arthroplasty (TKA). We agree that managing postsurgical pain is critical to patient recovery and relying on opioids is suboptimal, due to not only opioid-related adverse events but also the risk that short-term exposure can lead to chronic use [2e5]. We also agree that local infiltration is important to multimodal analgesia, which can reduce the need for opioids, and that the duration of traditional local anesthetics does not match the duration of acute postsurgical pain.Although some orthopedic surgeons support the use of "pain cocktails" combining local anesthetics, nonsteroidal antiinflammatory drugs, opioids, corticosteroids, and other medications (eg, clonidine), the evidence supporting them is difficult to interpret because the ingredients and doses vary, other interventions (eg, nerve block) are often coadministered, studies do not always use validated outcomes, and their designs can be prone to bias and confounding [6,7]. Furthermore, the use of combination products that are not approved by the US Food and Drug Administration for this use is problematic for a variety of reasons (eg, availability, preparation, sterility, stability, compatibility, dosing), and LB remains the only medication approved by the US Food and Drug Administration for single-dose administration into the surgical site to provide up to 72 hours of postsurgical analgesia.As is common with many healthcare innovations, a certain learning curve is required with LB, and its efficacy can be affected by the amount used, admixture with bupivacaine and saline, and the location and number of injection sites used. For example, although early studies on LB for TKA used only 60 mL (20 mL LB and 40 mL saline), a recently completed phase 4 study (NCT02713490) used 120 mL (20 mL LB, 20 mL bupivacaine 0.5%, and 80 mL saline) [8,9].The protocol for this multicenter phase 4 study with 16 academic and community hospitals and dozens of orthopedic surgeons was published in 2016 and includes the recommended administration technique in TKA based on existing evidence and surgeon experience [8]. It also describes the standardized presurgical, intrasurgical, and postsurgical multimodal analgesia regimen, as well as the validated patient-reported outcome measures used, including the visual analog scale (VAS) for pain at 0,4,6,8, 10, 12, 24, 28, 32, 36, 48, 52, 56, 60, and 72 hours, the overall benefit of analgesia score measured every 24 hours, and the timed up and go test and 6-minute walk test, both measured twice daily starting on the day of surgery. The repeated VAS measurements were required to calculate area under the curve, which more fully captures the time spent at different levels of pain severity compared with less frequent measurements.In contrast, it is unclear how often the VAS was used to measure pain in the study by DeClaire et al, how the ...

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Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Periarticular Anesthetic for Patients Undergoing Knee Replacement

et al. 2022

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for the Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK) Study Group IMPORTANCE More than half of patients who undergo knee replacement surgery report substantial acute postoperative pain.OBJECTIVE To 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.INTERVENTIONS Two 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. RESULTS Among 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 RELEVANCE This 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.

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Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study

Cited by 38 publications

References 13 publications

A Meta-Analysis Comparing Liposomal Bupivacaine and Traditional Periarticular Injection for Pain Control after Total Knee Arthroplasty

A Meta-Analysis Comparing Liposomal Bupivacaine and Traditional Periarticular Injection for Pain Control after Total Knee Arthroplasty

Letter to the Editor on “Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study”

Efficacy of Liposomal Bupivacaine and Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Periarticular Anesthetic for Patients Undergoing Knee Replacement

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