Evidence map›Paper›PMID 38914976›Full record

Trial reportBMC pregnancy and childbirth2024

Lidocaine spray vs mepivacaine local infiltration for suturing 1st/2nd grade perineal lacerations: a randomised controlled non-inferiority trial.

Stefano Restaino, Matilde Degano, Elisa Rizzante, Ginevra Battello, Federico Paparcura, Anna Biasioli, Martina Arcieri, Gabriele Filip, Luigi Vetrugno, Teresa Dogareschi and 6 more

Registry-linked trialAbstract readRandomized Controlled TrialComparative StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pregnancy and childbirth, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05201313 (Randomised Controlled Trial to Evaluate the Efficacy of Local Anaesthetic Application in Spray for the Repair of 1st- 2nd Perineal Lacerations Following Vaginal Delivery), which is not on this map. 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.

NCT05201313 phase3completednot on this map

Randomised Controlled Trial to Evaluate the Efficacy of Local Anaesthetic Application in Spray for the Repair of 1st- 2nd Perineal Lacerations Following Vaginal Delivery

TypeinterventionalSponsorAzienda Sanitaria-Universitaria Integrata di UdineRan2022 to 2022Enrolled136ConditionsVaginal Discharge, Perineum, Rupture, AnalgesiaArmsLidocaine Hydrochloride, Mepivacaine Injection
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Observational
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

16 authors.

Stefano RestainoDepartment of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.
Matilde DeganoDepartment of Medicine (DMED), University of Udine, Via Palladio, 8, Udine, UD, 33100, Italy. matildedegano@rocketmail.com.
Elisa RizzanteDepartment of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.
Ginevra BattelloDepartment of Medicine (DMED), University of Udine, Via Palladio, 8, Udine, UD, 33100, Italy.
Federico PaparcuraDepartment of Medicine (DMED), University of Udine, Via Palladio, 8, Udine, UD, 33100, Italy.
Anna BiasioliDepartment of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.
Martina ArcieriDepartment of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.
Gabriele FilipDepartment of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.
Luigi VetrugnoDepartment of Anesthesiology, Critical Care Medicine and Emergency, SS. Annunziata Hospital, Via Dei Vestini, Chieti, CH, 66100, Italy.
Teresa DogareschiDepartment of Anesthesia and Intensive Care Medicine, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.
Tiziana BoveDepartment of Medicine (DMED), University of Udine, Via Palladio, 8, Udine, UD, 33100, Italy.
Marco PetrilloGynecologic and Obstetric Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Piazza Università, 21, Sassari, 07100, Italy.
Giampiero CapobiancoGynecologic and Obstetric Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Piazza Università, 21, Sassari, 07100, Italy.
Giuseppe Vizzielli *Department of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy. giuseppe.vizzielli@uniud.it.
Lorenza Driul *Department of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.
LISPRAY Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPerineal lacerations are a very common complication of post-partum. Usually, the repair of 1st and 2nd-grade lacerations is performed after the administration of local anesthesia. Despite the great relevance of the problem, there are only a few studies about the best choice of local anesthetic to use during suturing. We performed a randomised controlled trial to evaluate the efficacy and safety of the use of a local anesthetic spray during the suturing of perineal lacerations in the post-partum.

methodsWe compared the spray with the standard technique, which involves the infiltration of lacerated tissues, using the NRS scale. 136 eligible women who had given birth at University Hospital of Udine were enrolled and randomly assigned to receive nebulization of Lidocaine hydrochloride 10% spray (experimental group) or subcutaneous/submucosal infiltration of mepivacaine hydrochloride (control group) during suturing of perineal laceration.

resultsThe lacerations included 84 1st-grade perineal traumas (61.7%) and 52 2nd-grade perineal traumas (38.2%). All the procedures were successfully completed without severe complications or serious adverse reactions. There were no statistically significant differences between the two groups in terms of blood losses or total procedure time. Moreover, there were no statistically significant differences in terms of NRS to none of the intervals considered. Regarding the application of the spray in the B group, in 36 cases (52.9%) it was necessary to improve the number of puffs previously supposed to be sufficient (5 puffs). Just in 3 cases, an additional injection was necessary (4.4%).

conclusionsOur study demonstrates that lidocaine spray alone can be used as a first line of local anesthetic during the closure of I-II-grade perineal lacerations, as it has comparable efficacy to mepivacaine infiltration.

trial registrationThe trial was recorded on https://clinicaltrials.gov . Identification number: NCT05201313. First registration date: 21/01/2022. Unique Protocol ID: 0042698/P/GEN/ARCS.

Indexed as

Anesthetics, LocalLacerationsLidocaineMepivacainePerineumSuture TechniquesAdultFemaleHumansPregnancyTreatment OutcomeAnesthetics, LocalLidocaineMepivacaineLidocaine sprayMepivacaine injectionsPerineal lacerationsPerineal suturingTopic anesthetic

Identifiers

PMID38914976
PMCPMC11194923

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.