Der analgetische Effekt des liposomalen Bupivacains im Vergleich zum Bupivacainhydrochlorid zur Vorbeugung postoperativer Schmerzen – Eine systematische Übersichtsarbeit und Metaanalyse mit sequentieller Studienanalyse
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Philipps-Universität Marburg
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Abstract
Background: The use of local anaesthetics in the post-operative setting is essentially limited by their restricted duration of action after single-dose application. In recent years, liposomal carrier systems with prolonged release kinetics (DepoFoam© technology; Pacira Pharmaceuticals Parsippany, NJ, USA), including liposomal bupivacaine, have become the focus of scientific attention with the aim of significantly extending the duration of action and at the same time reducing the use of opioids.
Objective: The aim of this systematic review and meta-analysis was to compare liposomal bupivacaine directly with conventional bupivacaine HCl in terms of its analgesia efficacy as measured by postoperative pain scores and time to first analgesic request, its influence on postoperative opioid consumption and side effects.
Methods: Without time or language restrictions, all relevant and high-quality randomised controlled trials (RCTs) of liposomal bupivacaine were filtered from the electronic databases, rigorously selected by several investigators and then analysed for the a priori defined primary and secondary endpoints. All application modalities of local anaesthetics (local and regional) and all surgical procedures were considered. The following endpoint parameters were analysed 24 and 72 hours after surgery: postoperative pain scores using the numerical rating scale of 0-10, postoperative consumption of morphine equivalents in milligrams, time to first analgesic requests in minutes and side effects.
Results: In total, data from 1867 patients from 23 randomised controlled trials (RCTs) were included in the meta-analysis (LB: n = 964; Bupi-HCl: n = 903). The meta-analysis of the primary endpoint "postoperative pain after 24 and 72 hours" only showed statistically significantly lower pain values in the LB group after 24 hours (MD -0.37; 95% CI: -0.56 to -0.19), but did not exceed the threshold of clinical relevance. With regard to the "postoperative consumption of morphine equivalents (MEQ)", a reduction in opioid consumption of around 15 % was demonstrated in the intervention group (LB). Due to a lack of data, no subsequent meta-analyses were carried out on the two secondary endpoints "time to first analgesic request postoperatively" and "side effects". Nausea/vomiting, dizziness and pruritus were the most common side effects observed with the two study drugs, but the rate was low in both trial groups.
Conclusion: Our meta-analysis was able to generate homogeneous data with a high level of evidence, demonstrating a lack of clinically relevant superiority of liposomal bupivacaine compared to bupivacaine HCl with regard to both postoperative pain and opioid consumption within the first 72 hours after surgery. Liposomal bupivacaine consistently demonstrated a high safety profile in its clinical use, consistent with data from preclinical safety studies. Finally, a trial sequential analysis (TSA) was used to demonstrate the conclusiveness and robustness of the evidence available to date. Taking into account the currently high costs of the new liposomal formulation (100 times more expensive than the standard bupivacaine HCl), no recommendation can be made for the routine use of LB in everyday clinical practice.
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Created: 2024Issued: 2025-02-12Updated: 2025-02-12
Faculty
Medizin
Publisher
Philipps-Universität Marburg
Language
ger
Data types
DoctoralThesis
Keywords
analgesic efficacy,
DFG-subjects
WirkdauerLiposomenRegionalanästhesiePostoperative SchmerzenBupivacainLokalanästhetika
DDC-Numbers
610
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Otremba, Berit Anna Birgit: Der analgetische Effekt des liposomalen Bupivacains im Vergleich zum Bupivacainhydrochlorid zur Vorbeugung postoperativer Schmerzen – Eine systematische Übersichtsarbeit und Metaanalyse mit sequentieller Studienanalyse. : Philipps-Universität Marburg 2025-02-12. DOI: https://doi.org/10.17192/z2025.0017.