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

INTERVENTION: 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) Concentration type: up to Concentration number: 50‐ Trade Name: mepivacaina cloridrato Product Name: mepivacaina cloridrato Product Code: [102614070] Pharmaceutical Form: Solution for injection INN or Proposed INN: MEPIVACAINA CLORIDRATO Current Sponsor code: 61528 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 20‐ CONDITION: 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 disorders System Organ Class: 10021428 ‐ Immune system disorders Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: To compare the effectiveness of treating pain during suturing of postpartum perineal lacerations with lidocaine spray vs skin infiltration. 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. Secondary Objective: / Timepoint(s) of evaluation of this end point: 12 months 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