A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY)

Tirotta, Christopher F.; Armendi, Alberto J. de; Horn, Nicole; Hammer, Gregory B.; Szczodry, Michal; Matuszczak, Maria; Wang, Natalie Q.; Scranton, Richard E.; Ballock, R. Tracy

doi:10.1016/j.jclinane.2021.110503

Cited by 16 publications

(25 citation statements)

References 23 publications

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“…Pharmacokinetic studies in this population have shown that, when administered at the recommended maximum dose of 4 mg/kg, plasma levels of bupivacaine are well below toxic levels, confirming the safety of this medication in children. 18 After being injected, the liposomes are slowly metabolized over multiple days, leading to a controlled, sustained release of bupivacaine. Surgical site infiltration of LB has been effective in controlling pain in pediatric patients undergoing spine surgery, but its use in ESPB in this population has not been evaluated to our knowledge.…”

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confidence: 99%

Erector Spinae Plane Blocks With Liposomal Bupivacaine for Pediatric Scoliosis Surgery

Stondell

Roberto

2022

JAAOS Glob Res Rev

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Pain management in patients with adolescent idiopathic scoliosis (AIS) undergoing posterior spinal fusion can be challenging. Various analgesic techniques are currently used, including enhanced recovery after surgery principles, spinal opioids or continuous epidural infusion, intravenous methadone, or surgical site infiltration of local anesthetic. Another recently developed technique, ultrasound-guided erector spinae plane blockade (ESPB), has been used successfully in spine surgery and may offer advantages because of its ease of placement, excellent safety profile, and opioid sparing qualities. Liposomal bupivacaine is a long-acting local anesthetic that was recently approved for infiltration and fascial plane blocks in pediatric patients of ages 6 years and older. This medication may prove to be beneficial when administered through ESPB in patients with AIS undergoing posterior spinal fusion because it can provide prolonged analgesia after a single injection. Here, we present a case report of two such patients, and we compare outcomes with a retrospective cohort of 13 patients with AIS who received IV methadone instead of ESPB. ESPB patients seemed to have less opioid use and shorter length of stay but higher pain scores, although the sample size is too small for meaningful statistical analysis. Future prospective trials are needed to see if differences in outcomes truly exist.

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confidence: 99%

Erector Spinae Plane Blocks With Liposomal Bupivacaine for Pediatric Scoliosis Surgery

Stondell

Roberto

2022

JAAOS Glob Res Rev

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“…Regarding the safety of liposomal bupivacaine in the pediatric population, Tirotta and colleagues found mostly mild to moderate adverse effects associated with the use of the liposomal bupivacaine and maintained that peak plasma concentrations of liposomal bupivacaine in children remained well below established cardiotoxicity and neurotoxicity levels. 16,17 In our study, patients were seen in the post-anesthesia care unit (PACU) for a distal motor exam postoperatively and within 5 to 7 days postoperatively for office exam. Patients were seen again at 3 weeks, 6 weeks, 12 weeks, 6 months, 9 months, 1 year, and 2 years for follow-up exams.…”

Section: Discussionmentioning

confidence: 99%

“…Although liposomal bupivacaine is readily available across the United States and documented safety has been maintained, the lag in adoption by the children's hospital stems from concern over cost. 16 With any prescribed medication, there is an associated cost, in this case, $214.75 for 10 mL. Conversely, patients with private insurance could opt for surgery at either the pediatric hospital or the surgery center, which provides liposomal bupivacaine injectable suspension, explaining the difference in distribution between groups.…”

Section: Discussionmentioning

confidence: 99%

Does Liposomal Bupivacaine Injectable Suspension Peripheral Nerve Block Further Aid in Decreasing At-home Narcotic Utilization in Children and Adolescents After Anterior Cruciate Ligament Reconstruction

Walls

Thomas

Kain

et al. 2023

Journal of Pediatric Orthopaedics

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Background: Opioid misuse and addiction among children and adolescents is an increasingly concerning problem. This study sought to determine whether liposomal bupivacaine injectable suspension admixture administered as a single-shot adductor canal peripheral nerve block (SPNB+BL) would decrease utilization of at-home opioid analgesics after anterior cruciate ligament reconstruction (ACLR) in adolescents compared with single-shot peripheral nerve block with bupivacaine (SPNB+B) alone. Methods: Consecutive ACLR patients with or without meniscal surgery by a single surgeon were enrolled. All received a preoperative single-shot adductor canal peripheral nerve block with either admixture of liposomal bupivacaine injectable suspension with 0.25% bupivacaine (SPNB+BL) or 0.25% bupivacaine alone (SPNB+B). Postoperative pain management included cryotherapy, oral acetaminophen, and ibuprofen. A prescription for 10 doses of hydrocodone/acetaminophen (5/325 mg) was provided in a sealed envelope with instructions to only use in the case of uncontrolled pain. Pain using the visual analog scale; number of consumed narcotics, acetaminophen, ibuprofen, and pain treatment satisfaction for the first 3 postoperative days were recorded. Statistical analysis was performed. Results: Fifty-eight patients were enrolled, the average age was 15±1.5 years (SPNB+B=32 patients, SPNB+BL=26 patients). Forty-seven patients (81%) did not require home opioids postoperatively. A significantly lower proportion of patients in the SPNB+BL group required opioids compared with control patients (7.7% vs. 28.1%, P=0.048). Average opioid use was 2 morphine milligram equivalents (MME), 0.4 pills (range, 0 to 20 MME). There were no differences in the visual analog scale or pain treatment satisfaction scores, other demographics, or other operative data. Inverse probability of treatment weighting analysis that was performed to account for any potential group differences revealed home opioid use between groups is significantly different (P<0.001). Conclusions: Liposomal bupivacaine injectable suspension admixture administered as an adductor canal nerve block in adolescents undergoing ACLR effectively reduces home opioid usage postoperatively compared with bupivacaine alone. Level of Evidence: Level II—prospective comparative study.

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“…Peak plasma levels of liposomal bupivacaine using 4 mg/kg have been previously studied and determined to be safe in children at this dose. 10 Monitoring included a 5-lead electrocardiogram with V1 to increase sensitivity in detecting arrhythmias. The team believed that the benefits in optimizing extended pain control with liposomal bupivacaine outweighed the risks in this case.…”

Section: Case Descriptionmentioning

confidence: 99%

Perioperative Management and Considerations for Patients With Voltage-Gated Sodium Channel Mutations: A Pediatric Case Report

Fahy

Emerling²,

Sterni³

2022

A&A Practice

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A 13-year-old girl with a voltage-gated sodium channel mutation (SCN8A)-associated intractable epilepsy presented for bilateral mastectomy for painful juvenile fibroadenomatosis. Sodium channel mutations are more frequently diagnosed with continued advances in genetic testing. Understanding the effects of sodium channel mutations is important to provide safe anesthetic care to these patients. In this article, we discuss what is known regarding the physiology of SCN8A channels and the anesthetic considerations when caring for patients with an SCN8A mutation.

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A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY)

Cited by 16 publications

References 23 publications

Erector Spinae Plane Blocks With Liposomal Bupivacaine for Pediatric Scoliosis Surgery

Erector Spinae Plane Blocks With Liposomal Bupivacaine for Pediatric Scoliosis Surgery

Does Liposomal Bupivacaine Injectable Suspension Peripheral Nerve Block Further Aid in Decreasing At-home Narcotic Utilization in Children and Adolescents After Anterior Cruciate Ligament Reconstruction

Perioperative Management and Considerations for Patients With Voltage-Gated Sodium Channel Mutations: A Pediatric Case Report

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