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Unanticipated transient sciatic nerve deficits from intra-wound liposomal bupivacaine injection during total hip arthroplasty.

ABSTRACT: Liposomal bupivacaine (Exparel®) is a novel formulation of local anesthetic used to provide extended postoperative analgesia as part of a multimodal pain control regimen in patients undergoing total joint arthroplasty. In the three total hip arthroplasty cases described, all patients exhibited a transient loss of neurologic function in the sciatic nerve distribution of the operated extremity lasting between 24 and 72 h during the immediate postoperative period. Due to the nature and duration of the deficits, it was concluded that they likely occurred as a result of unintended injection of the medication in close proximity to the sciatic nerve. To the best of our knowledge, these events have yet to be reported in the current literature. We recommend orthopaedic surgeons pay special attention during infiltration of the medication at the surgical site to avoid postoperative neurological deficits.

SUBMITTER: Bronson WH

PROVIDER: S-EPMC4926812 | biostudies-other | 2015 Jun

REPOSITORIES: biostudies-other

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Unanticipated transient sciatic nerve deficits from intra-wound liposomal bupivacaine injection during total hip arthroplasty.

Bronson Wesley H WH Doran James P JP Slover James J Perretta Donato D Iorio Richard R

Arthroplasty today 20150527 2

Liposomal bupivacaine (Exparel<sup>®</sup>) is a novel formulation of local anesthetic used to provide extended postoperative analgesia as part of a multimodal pain control regimen in patients undergoing total joint arthroplasty. In the three total hip arthroplasty cases described, all patients exhibited a transient loss of neurologic function in the sciatic nerve distribution of the operated extremity lasting between 24 and 72 h during the immediate postoperative period. Due to the nature and d ...[more]

PMID: 28326364

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Project description:BackgroundCurrently available local anesthetics approved for single-injection peripheral nerve blocks have a maximum duration of <24 hours. A liposomal bupivacaine formulation (EXPAREL, Pacira Pharmaceuticals, Inc., San Diego, CA), releasing bupivacaine over 96 hours, recently gained Food and Drug Administration approval exclusively for wound infiltration but not peripheral nerve blocks.MethodsBilateral single-injection femoral nerve blocks were administered in healthy volunteers (n = 14). For each block, liposomal bupivacaine (0-80 mg) was mixed with normal saline to produce 30 mL of study fluid. Each subject received 2 different doses, 1 on each side, applied randomly in a double-masked fashion. The end points included the maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle and tolerance to cutaneous electrical current in the femoral nerve distribution. Measurements were performed from baseline until quadriceps MVIC returned to 80% of baseline bilaterally.ResultsThere were statistically significant dose responses in MVIC (0.09%/mg, SE = 0.03, 95% confidence interval [CI], 0.04-0.14, P = 0.002) and tolerance to cutaneous current (-0.03 mA/mg, SE = 0.01, 95% CI, -0.04 to -0.02, P < 0.001), however, in the opposite direction than expected (the higher the dose, the lower the observed effect). This inverse relationship is biologically implausible and most likely due to the limited sample size and the subjective nature of the measurement instruments. While peak effects occurred within 24 hours after block administration in 75% of cases (95% CI, 43%-93%), block duration usually lasted much longer: for bupivacaine doses >40 mg, tolerance to cutaneous current did not return to within 20% above baseline until after 24 hours in 100% of subjects (95% CI, 56%-100%). MVIC did not consistently return to within 20% of baseline until after 24 hours in 90% of subjects (95% CI, 54%-100%). Motor block duration was not correlated with bupivacaine dose (0.06 hour/mg, SE = 0.14, 95% CI, -0.27 to 0.39, P = 0.707).ConclusionsThe results of this investigation suggest that deposition of a liposomal bupivacaine formulation adjacent to the femoral nerve results in a partial sensory and motor block of >24 hours for the highest doses examined. However, the high variability of block magnitude among subjects and inverse relationship of dose and response magnitude attests to the need for a phase 3 study with a far larger sample size, and that these results should be viewed as suggestive, requiring confirmation in a future trial.

Project description:Opioid analgesics have been a standard modality for postoperative pain management after total knee arthroplasty (TKA) but are also associated with increased risk of nausea, pruritus, vomiting, respiratory depression, prolonged ileus, and cognitive dysfunction. There is still a need for a method of anesthesia that can deliver effective long-term postoperative pain relief without incurring the high cost and health burden of opioids and nerve blocks.(1) Is liposomal bupivacaine-based periarticular injection (PAI) more effective than morphine-based spinal anesthesia or ropivacaine-based PAI in controlling postoperative pain after TKA? (2) Do patients treated with liposomal bupivacaine-based PAI experience fewer opioid-related adverse events compared with patients treated with morphine-based spinal anesthesia or ropivacaine-based PAI in controlling postoperative pain after TKA?This multicenter, blind trial randomized 119 patients undergoing TKA with spinal anesthesia to receive spinal anesthesia plus periarticular injection with liposomal bupivacaine (40 patients), spinal anesthesia with bupivacaine plus intrathecal morphine (41 patients) but no liposomal bupivacaine injection, or spinal anesthesia with bupivacaine (38 patients) and no liposomal bupivacaine injection. The two groups that did not receive periarticular liposomal bupivacaine did receive periarticular injection with ropivacaine, and all three groups had ketorolac (30 mg) plus epinephrine (1:1000) in the periarticular injections. Patients in all three groups received identical perioperative multimodal analgesic and antiemetic drugs. All patients were analyzed in the group to which they were randomized and no patients were lost to followup. The primary study endpoints were visual analog score (VAS) for pain and narcotic use during postoperative day 1. Secondary endpoints included side effects associated with narcotic administration during the hospital stay.Mean VAS pain in the liposomal bupivacaine PAI group was lower than that for the ropivacaine PAI group at 6 hours (1.8 ± 2.1 versus 3.3 ± 2.3, p = 0.005, mean difference: 1.5, 95% confidence interval [CI], 0.5-2.5) and 12 hours (1.5 ± 2.0 versus 3.3 ± 2.4, p < 0.001, mean difference: 1.8, 95% CI, 0.8-2.8) after surgery. The morphine spinal group had lower pain compared with the liposomal bupivacaine PAI group at 6 hours (0.9 ± 1.8 versus 1.8 ± 2.1, p = 0.035, mean difference: 1.0, 95% CI, 0.1-1.8), but there was no difference at 12 hours (0.8 ± 1.5 versus 1.5 ± 2.0, p = 0.086, mean difference: 0.7, 95% CI, -0.1 to 1.5). The magnitude of the differences at 6 and 12 hours are near the lower end of minimal clinically important differences reported in the literature, and thus the improvement shown in this study may only represent a small clinical improvement. Both the liposomal bupivacaine group (13% [five of 40]) and the ropivacaine group (5% [two of 38]) had fewer incidents of itching (pruritus) than the spinal morphine group (38% [15 of 41]) (p = 0.001).This prospective multicenter three-arm blind randomized controlled trial showed potentially improved pain control at 6 and 12 hours in the liposomal bupivacaine and intrathecal morphine groups compared with the ropivacaine group at the cost of much higher incidences of pruritus (itching) in the intrathecal morphine group. Based on these results, we prefer the use of PAI with liposomal bupivacaine as an alternative to spinal anesthesia with intrathecal morphine as a result of similar postoperative pain control and the potential for reducing adverse events.Level I, therapeutic study.

Project description:WHAT WE ALREADY KNOW ABOUT THIS TOPIC:WHAT THIS MANUSCRIPT TELLS US THAT IS NEW: BACKGROUND:: Although some trials suggest benefits of liposomal bupivacaine, data on real-world use and effectiveness is lacking. This study analyzed the impact of liposomal bupivacaine use (regardless of administration route) on inpatient opioid prescription, resource utilization, and opioid-related complications among patients undergoing total knee arthroplasties with a peripheral nerve block. It was hypothesized that liposomal bupivacaine has limited clinical influence on the studied outcomes. METHODS:The study included data on 88,830 total knee arthroplasties performed with a peripheral nerve block (Premier Healthcare Database 2013 to 2016). Multilevel multivariable regressions measured associations between use of liposomal bupivacaine and (1) inpatient opioid prescription (extracted from billing) and (2) length of stay, cost of hospitalization, as well as opioid-related complications. To reflect the difference between statistical and clinical significance, a relative change of -15% in outcomes was assumed to be clinically important. RESULTS:Overall, liposomal bupivacaine was used in 21.2% (n = 18,817) of patients that underwent a total knee arthroplasty with a peripheral nerve block. Liposomal bupivacaine use was not associated with a clinically meaningful reduction in inpatient opioid prescription (group median, 253 mg of oral morphine equivalents, adjusted effect -9.3% CI -11.1%, -7.5%; P < 0.0001) and length of stay (group median, 3 days, adjusted effect -8.8% CI -10.1%, -7.5%; P < 0.0001) with no effect on cost of hospitalization. Most importantly, liposomal bupivacaine use was not associated with decreased odds for opioid-related complications. CONCLUSIONS:Liposomal bupivacaine was not associated with a clinically relevant improvement in inpatient opioid prescription, resource utilization, or opioid-related complications in patients who received modern pain management including a peripheral nerve block.

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Unanticipated transient sciatic nerve deficits from intra-wound liposomal bupivacaine injection during total hip arthroplasty.

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Unanticipated transient sciatic nerve deficits from intra-wound liposomal bupivacaine injection during total hip arthroplasty.

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