Evidence map›Paper›PMID 37871332›Full record

Trial reportThe Journal of urology2024

Effectiveness of Liposomal Bupivacaine With Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Local Anesthetic for Children Undergoing Ambulatory Urologic Surgery: The Baby ORIOLES Randomized Clinical Trial.

Andrew T Gabrielson, Logan Galansky, Tamir Sholklapper, Chad Crigger, Hiten D Patel, Kelly Harris, Nora Haney, Yuezhou Jing, Ming-Hsien Wang, Charlotte Wu and 2 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in The Journal of urology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
2.9field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Andrew T GabrielsonJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.ORCID 0000-0001-9971-9813
Logan GalanskyJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Tamir SholklapperDepartment of Urology, Albert Einstein Medical Center, Philadelphia, Pennsylvania.
Chad CriggerJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Hiten D PatelDepartment of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Kelly HarrisDepartment of Urology, University of Colorado School of Medicine, Aurora, Colorado.
Nora HaneyJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Yuezhou JingJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Ming-Hsien WangJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Charlotte WuJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
John P GearhartJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Heather N Di CarloJames Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Johns Hopkins University · USEinstein Medical Center Philadelphia · USNorthwestern University · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe sought to determine if the addition of liposomal bupivacaine to bupivacaine hydrochloride improves opioid-free rate and postoperative pain scores among children undergoing ambulatory urologic surgery. MATERIALS AND

methodsA prospective, phase 3, single-blinded, single-center randomized trial with superiority design was conducted in children 6 to 18 years undergoing ambulatory urologic procedures between October 2021 and April 2023. Patients were randomized 1:1 to receive dorsal penile nerve block (penile procedures) or incisional infiltration with spermatic cord block (inguinal/scrotal procedures) with weight-based liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The primary outcome was opioid-free rate at 48 hours. Secondary outcomes included parents' postoperative pain measure scores, numerical pain scale scores, and weight-based opioid utilization at 48 hours and 10 to 14 days.

resultsWe randomized 104 participants, with > 98% (102/104) with complete follow-up data at 48 hours and 10 to 14 days. At interim analysis, there was no significant difference in opioid-free rate at 48 hours between arms (60% in the intervention vs 62% in the control group; estimated difference in proportion -1.9% [95% CI, -20%-16%];

conclusionsThe addition of liposomal bupivacaine to bupivacaine hydrochloride did not significantly improve opioid-sparing effect or postoperative pain compared with bupivacaine hydrochloride alone among children ≥ 6 years undergoing ambulatory urologic surgery.

Indexed as

Anesthetics, LocalBupivacaineAdolescentAnalgesics, OpioidChildHumansLiposomesMalePostoperative PainProspective StudiesAnalgesics, OpioidAnesthetics, LocalBupivacaineLiposomesambulatory surgical procedureslocal anesthetics

Identifiers

PMID37871332
OpenAlexW4387868900

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.