Clinical trial • Not applicable • Other

LIDOCAINE HYDROCHLORIDE for First-degree perineal laceration

Not applicable trial of LIDOCAINE HYDROCHLORIDE for First-degree perineal laceration.

Overview

Trial Therapeutic Area
Other
Trial Disease
First-degree perineal laceration
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
10-05-2024
First CTIS Authorization Date
23-07-2024

Trial design

Randomised, two arms: emla 25 mg/g + 25 mg/g cream (topical administration; product listed as emla 25 mg/g + 25 mg/g crema, max total amount listed 2 g) versus 2% lidocaine infiltration (lidocaína b. braun 20 mg/ml solución inyectable; infiltration route, max total amount listed 10 ml). specific dosing schedule/timing beyond route/formulation not specified.-controlled Not applicable trial across 1 site in Spain.

Randomised
Yes
Comparator
Two arms: EMLA 25 mg/g + 25 mg/g cream (topical administration; product listed as EMLA 25 mg/g + 25 mg/g crema, max total amount listed 2 g) versus 2% lidocaine infiltration (Lidocaína B. Braun 20 mg/ml solución inyectable; infiltration route, max total amount listed 10 ml). Specific dosing schedule/timing beyond route/formulation not specified.
Target Sample Size
84
Trial Duration For Participant
0.083

Eligibility

Recruits 84 No vulnerable population selected. The study excludes women with cognitive deficit or language barrier (see exclusion criteria). Subject information sheet and informed consent form are listed among documents but specific assent/consent procedures or multiple-language details are not provided in the available data..

Vulnerable Population
No vulnerable population selected. The study excludes women with cognitive deficit or language barrier (see exclusion criteria). Subject information sheet and informed consent form are listed among documents but specific assent/consent procedures or multiple-language details are not provided in the available data.

Inclusion criteria

  • {"criterion_text":"- Single eutocic delivery."}
  • {"criterion_text":"- Gestational age greater than or equal to 37 weeks"}
  • {"criterion_text":"- Presence of first degree laceration/tear requiring suturing"}
  • {"criterion_text":"- Postpartum woman of age greater than or equal to 18 years"}

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- The values ​​of the Visual Analogue Scale (VAS) of pain modified according to how they express women.","definition_or_measurement_approach":"Pain measured using a modified Visual Analogue Scale (VAS) as reported by the women (no further measurement details provided)."}

Secondary endpoints

  • {"endpoint_text":"- Characteristics of the tear: location.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 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).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Characteristics of the newborn: weight and sex.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Characteristics of women: parity and age.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
84
Recruitment Window Months
11
Consent Approach
A subject information sheet and informed consent form are listed in the study documents. Consent is to be provided by the participant (postpartum women aged ≥18 years). No details on assent/parental consent (not applicable) or languages of documentation are provided in the available data.

Geography

Total Number Of Sites
1
Total Number Of Participants
84

Spain

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
649
Number Of Sites
1
Number Of Participants
84

Sites

Site Name
Hospital Universitario De La Plana
Department Name
Paritorio
Principal Investigator Name
Eva Vilar Yebra
Principal Investigator Email
resishlp26@gmail.com
Contact Person Name
Eva Vilar Yebra
Contact Person Email
resishlp26@gmail.com
Number Of Participants
84

Sponsor

Primary sponsor

Full Name
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
Organisation Type
Patient organisation/association
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Lidocaína B. Braun 20 mg/ml solución inyectable
Active Substance
LIDOCAINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INFILTRATION
Route
INFILTRATION
Authorisation Status
Authorised
Maximum Dose
10 ml
Investigational Product Name
EMLA 25 mg/g + 25 mg/g crema
Active Substance
LIDOCAINE; PRILOCAINE
Modality
Small molecule
Routes Of Administration
TOPICAL ADMINISTRATION
Route
TOPICAL ADMINISTRATION
Authorisation Status
Authorised
Maximum Dose
2 g
Combination Treatment
Yes

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