Evidence map›Paper›PMID 34315419›Full record

ArticleBMC anesthesiology2021

Pharmacokinetics and safety of liposomal bupivacaine after local infiltration in healthy Chinese adults: a phase 1 study.

Bernard My Cheung, Pauline Yeung Ng, Ying Liu, Manman Zhou, Vincent Yu, Julia Yang, Natalie Q Wang

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in BMC anesthesiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04158102 (A Phase 1, Open Label Study to Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.3field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04158102 phase1completednot on this map

A Phase 1, Open Label Study to Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects

TypeinterventionalSponsorNuance Pharma (shanghai) Co., LtdRan2019 to 2019Enrolled20ConditionsHealthy SubjectsArmsBupivacaine liposome injectable suspension
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 14 citations in OpenAlex.

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  12. Liposomal bupivacaine in lower extremity arthroplasty: a comprehensive review.Frontiers in pain research (Lausanne, Switzerland) · 2026
    Review
  13. Review
  14. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 3 countries.

Bernard My CheungDepartment of Medicine, University of Hong Kong, Queen Mary Hospital Pok Fu Lam, 102 Pok Fu Lam Road, Hong Kong, China. mycheung@hku.hk.
Pauline Yeung NgDepartment of Medicine, University of Hong Kong, Queen Mary Hospital Pok Fu Lam, 102 Pok Fu Lam Road, Hong Kong, China.
Ying LiuNuance Biotech Co., Ltd, Room 510, Building 2, CITIC Fortune Plaza, 9 Guangan Road, Fengtai District, Beijing, China.
Manman ZhouNuance Biotech Co., Ltd, Room 2106, Ciros Plaza, 388 Nanjing Road W, Huangpu District, Shanghai, China.
Vincent YuPacira BioSciences, Inc., 5 Sylvan Way, Parsippany-Troy Hills, NJ, USA.
Julia YangPacira BioSciences, Inc., Parsippany, NJ, USA.
Natalie Q WangPacira BioSciences, Inc., 5 Sylvan Way, Parsippany-Troy Hills, NJ, USA.
Pacira (United States) · USCITIC Group (China) · CNQueen Mary Hospital · CNTB Alliance · USUniversity of Hong Kong · HK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLiposomal bupivacaine (LB) is a long-acting formulation of bupivacaine. The safety and efficacy of LB has been demonstrated across surgical procedures. However, pharmacokinetic (PK) parameters and safety of LB in the Chinese population have not been assessed.

methodsIn this single-arm, single center, phase 1, open-label study, PK and safety of local infiltration with LB 266 mg were assessed in healthy Chinese adults. Eligible participants were aged 18 to 55 years with biologic parents and grandparents of Chinese ethnicity, in generally good health (i.e., no clinically significant abnormalities), and with a body mass index (BMI) 19.0 to 24.0 kg/m

resultsParticipants (N = 20) were predominantly men (80 %); mean age was 32 years; and mean BMI was 21.8 kg/m

conclusionsAfter single-dose administration of LB, PK measures were similar to a previously reported profile in US adults. The highest observed peak plasma concentration of bupivacaine was several-fold below the plasma concentration threshold accepted as being associated with neurotoxicity or cardiotoxicity (2000-4000 ng/mL). These data support that LB is well tolerated and safe in individuals of Chinese descent.

trial registrationNCT04158102 (ClinicalTrials.gov identifier), Date of registration: November 5, 2019.

Indexed as

Asian PeopleAdultAnesthetics, LocalBupivacaineFemaleHumansLiposomesMaleYoung AdultAnesthetics, LocalBupivacaineLiposomesAnalgesiaAnesthesiaBridgingPharmacologyTolerability

Identifiers

PMID34315419
PMCPMC8314475
OpenAlexW3186514069

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.