Efficacy and safety of the application of local anaesthetic in spray form for the repair of 1st- 2nd perineal lacerations following vaginal delivery
- 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: 20.0Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2021-002257-28-IT
- Lead Sponsor
- AZIENDA OSPEDALIERO-UNIVERSITARIA UDINE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 128
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method