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Clinical Trial Summary

Randomized controlled trial aimed at evaluating the efficacy and safety of the use of a local anesthetic spray, commonly used in clinical practice as off-label, during the suturing of perineal lacerations in post-partum, comparing it with the standard technique that involves the infiltration of lacerated tissues, by administering a NRS card at the end of the procedure (time 1).


Clinical Trial Description

The study aims to compare the effectiveness of pain treatment during the suturing of postpartum perineal lacerations with lidocaine spray vs skin infiltration. The hypothesis of the study is that the treatment of perineal pain with nebulization demonstrates greater efficacy vs the infiltration of mepivacaine hydrochloride in a population of patients subjected to suturing of postpartum lacerations. Eligible women will be randomly assigned to receive, after wound disinfection and cleansing of bleeding with mild haemostasis: 1. nebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm (experimental group). 2. subcutaneous / submucosal infiltration depending on the type of perineal laceration of 10 ml of 1% mepivacaine hydrochloride (control group). Since there are no previous published studies, regarding the use of nebulized lidocaine hydrochloride for the suturing of perineal lacerations, the number of puffs chosen was chosen based on what is indicated on the technical data sheet of lidocaine hydrochloride and making use of previous studies in the gynecological field, but with other indications. The suture will be made once anesthetic efficacy is achieved, as per pharmacological indications. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05201313
Study type Interventional
Source Azienda Sanitaria-Universitaria Integrata di Udine
Contact
Status Completed
Phase Phase 3
Start date January 20, 2022
Completion date August 8, 2022

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