Evidence map›Paper›PMID 37386624›Full record

ArticleJournal of anesthesia, analgesia and critical care2021

Pain management during labor: use of intermittent drug delivery devices for improvement of obstetric and neonatal outcome and reduction of healthcare burden: A large non-inferiority randomized clinical trial.

Laura Rinaldi, Anna Maria Ghirardini, Raffaella Troglio, Valentina Bellini, Lara Donno, Susanna Biondini, Emanuela Biagioni, Marco Baciarello, Elena Bignami, Massimo Girardis

Erratum issuedAbstract read
In one paragraph

Article in Journal of anesthesia, analgesia and critical care, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Laura RinaldiAnesthesia and Intensive Care Unit, University Hospital of Modena, L.go del Pozzo 71, 41125, Modena, Italy. rinaldi.laura@unimore.it.
Anna Maria GhirardiniAnesthesia and Intensive Care Unit, University Hospital of Modena, L.go del Pozzo 71, 41125, Modena, Italy.
Raffaella TroglioAnesthesiology and Critical Care Division, Department of Medicine and Surgery, University of Parma, Viale Gramsci 14, 43126, Parma, Italy.
Valentina BelliniAnesthesiology and Critical Care Division, Department of Medicine and Surgery, University of Parma, Viale Gramsci 14, 43126, Parma, Italy.
Lara DonnoAnesthesia and Intensive Care Unit, University Hospital of Modena, L.go del Pozzo 71, 41125, Modena, Italy.
Susanna BiondiniAnesthesiology and Critical Care Division, Department of Medicine and Surgery, University of Parma, Viale Gramsci 14, 43126, Parma, Italy.
Emanuela BiagioniAnesthesia and Intensive Care Unit, University Hospital of Modena, L.go del Pozzo 71, 41125, Modena, Italy.
Marco BaciarelloAnesthesiology and Critical Care Division, Department of Medicine and Surgery, University of Parma, Viale Gramsci 14, 43126, Parma, Italy.
Elena BignamiAnesthesiology and Critical Care Division, Department of Medicine and Surgery, University of Parma, Viale Gramsci 14, 43126, Parma, Italy.
Massimo GirardisAnesthesia and Intensive Care Unit, University Hospital of Modena, L.go del Pozzo 71, 41125, Modena, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAutomated continuous epidural administration of local anesthetics provides a more stable analgesic block with decreasing of healthcare staff compared to manual boluses administration (TOP-UP) but is associated to high rate of operative vaginal delivery. We hypothesized that the use of programmed intermittent automated boluses (PIEB) is able to provide a good quality of analgesia and decreasing of anesthesiologic workload without increasing the rate of instrumental vaginal birth in comparison with TOP-UP technique. Laboring nulliparous woman aged between 18 and 46 years were randomized to epidural analgesia with 0.0625% levobupivacaine and sufentanil administered by PIEB or by TOP-UP techniques. Primary outcome was instrumental vaginal delivery rate and secondary outcomes were quality of analgesia, total and time-related drugs doses used, motor block, newborn outcome, and anesthesiologic workload.

resultsSix hundred twenty-nine were randomized, and 628 were included in the intention-to-treat analysis. The rate of instrumental vaginal delivery was similar in the PIEB and TOP-UP groups (13.2% vs 9.7%, OR 1.4 95% CI 0.8 to 2.5; p 0.21). There was no difference between groups regarding mode of delivery (cesarean section vs vaginal birth), newborn outcome, and motor block. Patients in the PIEB group received more total and time-related drugs doses and a better quality of analgesia. Anesthesiological workload was significantly reduced in the PIEB group.

conclusionsOur study demonstrated that epidural anesthesia with programmed intermittent epidural boluses by an automated device provides an effective and safe management of labor analgesia with improvement of pain control and sparing of man workload compared to manual top-up protocols.

Indexed as

DeliveryIntermittent epidural analgesiaLabor painPatient controlled epidural analgesia

Identifiers

PMID37386624
PMCPMC10208448

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Registered trials

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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.