학술논문
Lidocaine spray vs mepivacaine local infiltration for suturing 1st/2nd grade perineal lacerations: a randomised controlled non-inferiority trial.
Document Type
Academic Journal
Author
Restaino S; Department of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.; PhD School in Biomedical Sciences, Gender Medicine, Child and Women Health, University of Sassari, Sassari, Sardinia, Italy.; Degano M; Department of Medicine (DMED), University of Udine, Via Palladio, 8, Udine, UD, 33100, Italy. matildedegano@rocketmail.com.; Rizzante E; Department of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.; Battello G; Department of Medicine (DMED), University of Udine, Via Palladio, 8, Udine, UD, 33100, Italy.; Paparcura F; Department of Medicine (DMED), University of Udine, Via Palladio, 8, Udine, UD, 33100, Italy.; Biasioli A; Department of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.; Arcieri M; Department of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.; Filip G; Department of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.; Vetrugno L; Department of Anesthesiology, Critical Care Medicine and Emergency, SS. Annunziata Hospital, Via Dei Vestini, Chieti, CH, 66100, Italy.; Dogareschi T; Department of Anesthesia and Intensive Care Medicine, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.; Bove T; Department of Medicine (DMED), University of Udine, Via Palladio, 8, Udine, UD, 33100, Italy.; Department of Anesthesia and Intensive Care Medicine, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.; Petrillo M; Gynecologic and Obstetric Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Piazza Università, 21, Sassari, 07100, Italy.; Capobianco G; Gynecologic and Obstetric Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Piazza Università, 21, Sassari, 07100, Italy.; Vizzielli G; 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.; Department of Medicine (DMED), University of Udine, Via Palladio, 8, Udine, UD, 33100, Italy. giuseppe.vizzielli@uniud.it.; Driul L; Department of Gynecology and Obstetrics, ASUFC University-Hospital of Friuli Centrale, Piazzale Santa Maria Della Misericordia, 15, Udine, UD, 33100, Italy.; Department of Medicine (DMED), University of Udine, Via Palladio, 8, Udine, UD, 33100, Italy.
Source
Publisher: BioMed Central Country of Publication: England NLM ID: 100967799 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2393 (Electronic) Linking ISSN: 14712393 NLM ISO Abbreviation: BMC Pregnancy Childbirth Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Perineal 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.
Methods: We 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.
Results: The 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%).
Conclusions: Our 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 Registration: The trial was recorded on https://clinicaltrials.gov . Identification number: NCT05201313. First registration date: 21/01/2022. Unique Protocol ID: 0042698/P/GEN/ARCS.
(© 2024. The Author(s).)
Methods: We 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.
Results: The 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%).
Conclusions: Our 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 Registration: The trial was recorded on https://clinicaltrials.gov . Identification number: NCT05201313. First registration date: 21/01/2022. Unique Protocol ID: 0042698/P/GEN/ARCS.
(© 2024. The Author(s).)