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

Phase 1

Recruiting

Conditions: First-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]

Registration Number: CTIS2024-512728-12-00

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 84

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare the efficacy of injected versus topical lidocaine (EMLA) administration in<br>women with first-degree perineal tear to evaluate pain, both in administration<br>of the anesthetic as well as in the repair of perineal tissue and in the two hours after delivery.;Secondary Objective: Know the pain expressed by the woman during the administration of the anesthetic and during suturing and two hours postpartum., Describe the need for additional analgesia, Describe the characteristics of both groups;Primary end point(s): The values ??of the Visual Analogue Scale (VAS) of pain modified according to how they express women.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Characteristics of the tear: location.;Secondary end point(s):Characteristics of childbirth and postpartum: onset of labor, use of alternative therapies to pain management and performing uninterrupted skin-to-skin for the two hours postpartum (except when the newborn is weighed).;Secondary end point(s):Characteristics of the newborn: weight and sex.;Secondary end point(s):Characteristics of women: parity and age.