A randomized clinical trial to compare topical lidocaine-prilocaine cream (Emla) versus 2% lidocaine infiltration to first-degree perineal tears repair - DES-26-E(C)A

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana0 sites84 target enrollmentMay 10, 2024

ConditionsFirst-dregree perineal laceration MedDRA version: 21.1Level: LLTClassification code: 10016705Term: First-degree perineal laceration during delivery Class: 10022117 Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: First-dregree perineal laceration
Sponsor: Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
Enrollment: 84
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 10, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Eligibility Criteria

Inclusion Criteria

•Single eutocic delivery., Gestational age greater than or equal to 37 weeks, Presence of first degree laceration/tear requiring suturing, Postpartum woman of age greater than or equal to 18 years

Exclusion Criteria

•Administration of epidural analgesia., Adverse reactions to any local anesthetic in the past, Infection at the site of anesthetic administration., Heart, kidney or liver disease, Denial of participation in the study, Language barrier. Woman with cognitive deficit or any other mental, physical or social situation that makes it difficult understanding of the study, Woman with cognitive deficit or any other mental, physical or social situation that makes understanding the study difficult.

Outcomes

Primary Outcomes

Not specified

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