Liposomal bupivacaine interscalene nerve block in shoulder arthroplasty is not superior to plain bupivacaine: a double-blinded prospective randomized control trial

Hattrup, Steven J.; Chung, Andrew S.; Rosenfeld, David M.; Misra, Lopa; Koyyalamudi, Veerandra; Ritz, Matthew L; Tokish, John M.

doi:10.1016/j.jse.2020.09.017

Cited by 24 publications

(37 citation statements)

References 29 publications

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“…Our inability to demonstrate an improvement in opioid use postoperatively is consistent with previous work 9–11. Indeed, LB interscalene blocks have been shown to reduce opioid requirements following shoulder surgery only when compared with placebo interscalene blocks 8.…”

Section: Discussionsupporting

confidence: 89%

“…Indeed, LB interscalene blocks have been shown to reduce opioid requirements following shoulder surgery only when compared with placebo interscalene blocks 8. Our data are further evidence that the addition of LB to bupivacaine appears to not have an opioid sparing effect when compared with bupivacaine alone9 10 or with adjuvant dexamethasone11 used in interscalene block.…”

Section: Discussionsupporting

confidence: 56%

“…Vandepitte et al found a statistical reduction in worst pain scores up to 7 days after surgery9; however, this difference did not reach their predefined clinically relevant threshold. Hattrup et al detected an improvement in average visual analog pain scores only on the second day post surgery in patients receiving LB 10. We found clinically relevant improvements in median worst pain scores 24 and 72 hours after surgery using the minimum clinically important difference of 1.0 defined by Myles et al 12.…”

Section: Discussionmentioning

confidence: 48%

“…When compared with placebo, LB interscalene blocks reduce pain scores and opioid consumption after major shoulder surgery 8. However, when compared with traditional bupivacaine interscalene blocks, conflicting results are reported with its addition 9 10. Recent work has demonstrated that interscalene nerve blocks using standard bupivacaine plus dexamethasone provided similar analgesia compared with LB 11…”

Section: Introductionmentioning

confidence: 99%

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Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial

Flaherty

Berg

Harrison

et al. 2022

Reg Anesth Pain Med

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BackgroundSingle-injection interscalene brachial plexus blocks are used for analgesia for rotator cuff repair (RCR) but have limited duration. The value of adding liposomal bupivacaine (LB) to prolong single-injection interscalene blocks is unclear. The purpose of this trial is to evaluate the addition of LB to regular bupivacaine interscalene blocks for patients undergoing arthroscopic RCR.MethodsIn this prospective, randomized trial, 70 patients undergoing primary RCR with equal group allocation were randomized by random number generator to receive an interscalene block with 20 mL of 0.5% bupivacaine or 10 mL 0.5% bupivacaine plus 133 mg LB. The primary outcome was cumulative opioid consumption within 72 hours of the procedure. Secondary outcomes included maximum pain scores and quality of recovery 15 survey scores.Results70 of the 80 randomized patients were included in final analysis following exclusion for protocol violations and loss to follow-up. Cumulative opioid consumption (oral morphine equivalents) within 72 hours in patients receiving LB was a median (IQR) of 31.9 mg (0, 73.1) compared with 45.0 mg (15.0, 108.8) among patients receiving bupivacaine alone (p=0.312). Patients receiving LB demonstrated mixed results regarding worst pain scores with improvements at 24 hours and 72 hours, but not 48 hours.ConclusionsLB added to bupivacaine interscalene blocks does not reduce opioid consumption within 72 hours following arthroscopic RCR.Trial registration numberNCT03587584.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 56%

Section: Discussionmentioning

confidence: 48%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial

Flaherty

Berg

Harrison

et al. 2022

Reg Anesth Pain Med

View full text Add to dashboard Cite

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“…While there are pharmacokinetic and pharmacodynamic differences between the various long-acting anesthetics used in brachial plexus NBs, there is no clear evidence demonstrating superiority in terms of reducing postoperative VAS scores and opioid requirements. 2 , 18 , 33 , 37 , 48 Our results similarly demonstrate consistent benefits in reduced opioid use in the first 24 hours after ARCR despite what specific formulation of long-acting anesthetic was used. In addition, the use of nonopioid analgesics as part of multimodal pain management improves patient comfort and reduces opioid exposure.…”

Section: Discussionsupporting

confidence: 68%

Use of Opioids in the Early Postoperative Period After Arthroscopic Rotator Cuff Repair: A Systematic Review

Davis

Sandler

Dunn

et al. 2022

Orthopaedic Journal of Sports Medicine

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Background: Postoperative treatment plans after orthopaedic procedures frequently include opioids for pain relief. Purpose: To evaluate opioid use in the early postoperative phase after arthroscopic rotator cuff repair (ARCR) to develop a procedure-specific understanding of the current role of opioids in pain management for this procedure. Study Design: Systematic review; Level of evidence, 4. Methods: A PubMed search was used to identify eligible studies. Data on patient demographics, visual analog scale pain scores, and opioid use patterns (in morphine milligram equivalents [MMEs]) were collected and assessed. Cumulative MMEs were reported on postoperative day (POD) zero, and mean MMEs were reported on subsequent PODs (days 1, 2, 3, 5, 7, and 14). Metaregression, I 2 indices, and Cochran Q tests were used to evaluate study variation, heterogeneity, and variance. Results: A total of 1487 patients in 22 studies were included in the analysis. An estimated 51% (95% CI, 31%-70%) of patients with nerve blocks (NBs) were opioid-free through POD-0 versus 40% (95% CI, 1.2%-97%) of patients without NBs, which increased to 65% (95% CI, 55%-74%) versus 25% (95% CI, 1.7%-86%) by POD-1. Opioid requirements were highest in the first 72 hours after ARCR. NB use reduced opioid requirement on POD-0 compared with no NB use (15.8 vs 45.0 MMEs, respectively; P < .001) but did not reduce requirements after that. In addition, NB use led to a statistically significant increase in opioid requirements on POD-7 (28.6 vs 9.5 MMEs, respectively; P < .001). Using a model that assumes stable opioid requirements between our time points, weighted mean cumulative opioid consumption was 163 MMEs in the first week and 273 MMEs in the first 2 weeks (150 and 287 MMEs in patients with NB; 180 and 261 MMEs in patients without NB, respectively). Conclusion: Opioid use is relatively common in the early postoperative period after ARCR. Pain scores and opioid requirements may spike on POD-1; however, patients should be educated and reassured that they will gradually decrease usage over the initial 2-week postoperative period.

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Liposomales Bupivacain – kein Durchbruch in der postoperativen Schmerztherapie

et al. 2022

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ZusammenfassungEine der größten Limitationen in der Anwendung von Lokalanästhetika liegt in ihrer begrenzten Wirkdauer. In den letzten Jahren wurden liposomale Formulierungen mit prolongierter Freisetzungskinetik entwickelt, um die pharmakologische Wirkdauer der einzeitigen peripheren Regionalanästhesie („Single-shot-Verfahren“) zeitlich „zu strecken“ und somit eine verlängerte Therapiedauer zu bewirken. Im Fokus stehen hierbei insbesondere das Erreichen einer postoperativen Schmerzfreiheit von mindestens 24 h (oder besser sogar 48 h) und dadurch eine frühzeitige Mobilisation der Patienten unter Bedarfsmedikation bei allenfalls geringfügig erhaltener sensorischer Blockade und ohne motorische Einschränkungen (so zumindest die Idealvorstellung). Eine solche moderne pharmakologische Option mit theoretisch deutlich verlängerter Wirkdauer findet sich hierbei in der Gruppe der Amidlokalanästhetika, das liposomale Bupivacain. Bedingt durch einen multivesikulären Liposomenaufbau führt die retardierte Freisetzung der aktiven Komponente Bupivacain-HCl zu einer theoretischen pharmakologischen Wirksamkeit bis zu 72 h. In bisherigen Studien zeigte sich dabei konsistent ein vergleichbares Sicherheitsprofil zum herkömmlichen Bupivacain-HCl. Seit 2011 ist das liposomale Bupivacain unter dem Handelsnamen Exparel© (Fa. Pacira Pharmaceuticals, Parsippany, NJ, USA) von der amerikanischen Food and Drug Administration (FDA) zugelassen. Die Anwendung ist derzeit jedoch auf lokale Wundinfiltration, „Transversus-abdominis-plane“(TAP)-Blockaden und interskalenäre Nervenblockaden des Plexus brachialis beschränkt. Im Jahr 2020 erteilte auch die Europäische Arzneimittel-Agentur (EMA) dem Einsatz des liposomalen Bupivacains für Blockaden des Plexus brachialis oder des N. femoralis sowie als Feldblock bzw. zur Wundinfiltration zur Behandlung postoperativer Schmerzen eine Zulassung. Bislang zeigte sich die Studienlage zur klinischen Effektivität des liposomalen Bupivacains stark heterogen. Aktuelle Metaanalysen, welche die Ergebnisse randomisierter, kontrollierter Studien zur analgetischen Wirksamkeit des liposomalen Bupivacains in verschiedenen Anwendungsbereichen zusammenfassen, weisen nun konsensuell keinen klinisch relevanten Benefit durch die neue liposomale Formulierung nach und erbringen ausreichend Evidenz, um den Diskurs um das liposomale Bupivacain beenden zu können. Ziel dieser Arbeit ist es, dem Leser einen aktuellen evidenzbasierten Überblick zu dieser Substanz zu geben.

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Liposomal bupivacaine interscalene nerve block in shoulder arthroplasty is not superior to plain bupivacaine: a double-blinded prospective randomized control trial

Cited by 24 publications

References 29 publications

Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial

Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial

Use of Opioids in the Early Postoperative Period After Arthroscopic Rotator Cuff Repair: A Systematic Review

Liposomales Bupivacain – kein Durchbruch in der postoperativen Schmerztherapie

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