Efficacy and safety of the application of local anaesthetic in spray form for the repair of 1st- 2nd perineal lacerations following vaginal delivery

Randomised controlled trial to evaluate the efficacy of local anaesthetic application in spray for the repair of 1st- 2nd perineal lacerations following vaginal delivery - Lispray

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002257-28-IT

Enrollment

128

Registered

2021-10-22

Start date

2021-11-09

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Considering the high percentage of grade 1 and 2 perineal lacerations, it is evident that another route of administration of the anaesthetic could be of great help in further reducing the discomfort of the woman. In particular, the use of topical lidocaine spray administered by nebulisation onto the wound could ensure greater clinical efficacy on pain control, pain-free administration, and ease of use by operators. MedDRA version: 20.0 Level: SOC Classification code 10021428 Term: Immune system

Interventions

Trade Name: Ecocain Product Name: Ecocain Product Code: [027388091] Pharmaceutical Form: INN or Proposed INN: LIDOCAINA CLORIDRATO Current Sponsor code: 61528 Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Grade I or II post-partum perineal laceration requiring suturing; - full-term delivery (beyond 36 weeks and 6 days of gestation) - over 18 years of age - childbirth at the top; - understanding of the Italian language; - consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 128 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - epidural anaesthesia during the 2 hours preceding delivery; - operative delivery with the application of forceps or suction cups; - psychiatric pathology; - twin births; - known allergies to study instruments - previous adverse reactions to local anaesthetics

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effectiveness of treating pain during suturing of postpartum perineal lacerations with lidocaine spray vs skin infiltration.;Secondary Objective: /;Primary end point(s): To evaluate the efficacy and safety of using a local anaesthetic spray, commonly used in clinical practice as an off label, during suturing of perineal lacerations in the postpartum period, comparing it with the standard technique involving infiltration of the lacerated tissues.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: To compare the effectiveness of treating pain during suturing of postpartum perineal lacerations with lidocaine spray vs skin infiltration.;Secondary Objective: /;Primary end point(s): To evaluate the efficacy and safety of using a local anaesthetic spray, commonly used in clinical practice as an off label, during suturing of perineal lacerations in the postpartum period, comparing it with the standard technique involving infiltration of the lacerated tissues.;Timepoint(s) of evaluation of this end point: 12 months

—

Countries

Italy

Contacts

Public ContactSOC Ginecologia ed Ostetricia

Azienda Sanitaria Universitaria Friuli Centrale - Udine

stefano.restaino@asufc.sanita.fvg.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026