Overview
Sponsor-declared trial summary
First-dregree perineal laceration
Compare the efficacy of injected versus topical lidocaine (EMLA) administration in women with first-degree perineal tear to evaluate pain, both in administration of the anesthetic as well as in the repair of perineal tissue and in the two hours after delivery.
Key facts
- Sponsor
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 12 Aug 2024 → ongoing
- Decision date (initial)
- 2024-07-23
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Hospital Universitari de La Plana
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Compare the efficacy of injected versus topical lidocaine (EMLA) administration in
women with first-degree perineal tear to evaluate pain, both in administration
of the anesthetic as well as in the repair of perineal tissue and in the two hours after delivery.
Secondary objectives 3
- 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
Conditions and MedDRA coding
First-dregree perineal laceration
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10016705 | First-degree perineal laceration during delivery | 10022117 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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 7
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The values of the Visual Analogue Scale (VAS) of pain modified according to how they express women.
Secondary endpoints 4
- Characteristics of the tear: location.
- 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).
- Characteristics of the newborn: weight and sex.
- Characteristics of women: parity and age.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD6832742 · Product
- Active substance
- Lidocaine
- Pharmaceutical form
- CREAM
- Route of administration
- TOPICAL ADMINISTRATION
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB20 — COMBINATIONS
- Marketing authorisation
- 61.096
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lidocaína B. Braun 20 mg/ml solución inyectable
PRD575184 · Product
- Active substance
- Lidocaine Hydrochloride
- Substance synonyms
- 2-DIETHYLAMINO-N-(2,6-DIMETHYLPHENYL)ACETAMIDE HYDROCHLORIDE, LIGNOCAINE HYDROCHLORIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 10 ml millilitre(s)
- Max total dose
- 10 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01B — ANESTHETICS, LOCAL
- Marketing authorisation
- 44792
- MA holder
- B.BRAUN MEDICAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Sponsor organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Address
- Avenida Cataluna No 21
- City
- Valencia
- Postcode
- 46020
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Contact name
- Eva Vilar Yebra y Andrea Aparicio Sanz
Public contact point
- Organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Contact name
- Eva Vilar Yebra y Andrea Aparicio Sanz
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 84 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-08-12 | 2024-08-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF For publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2024-512728-12_v1_1_For Public | 1.1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-10 | Spain | Acceptable 2024-07-17
|
2024-07-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-15 | Spain | Acceptable | 2025-10-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-31 | Spain | Acceptable | 2026-03-31 |