Randomised Controlled Trial to Evaluate the Efficacy of Local Anaesthetic Application in Spray for the Repair of 1st- 2nd Perineal Lacerations Following Vaginal Delivery

0042698/P/GEN/ARCS

Randomized controlled trial aimed at evaluating the efficacy and safety of the use of a local anesthetic spray, commonly used in clinical practice as off-label, during the suturing of perineal lacerations in post-partum, comparing it with the standard technique that involves the infiltration of lacerated tissues, by administering a NRS card at the end of the procedure.

2022-01-20

2022-07-08

2022-08-08

Completed

Early phase I

136

Inclusion Criteria: * have a 1st or 2nd degree postpartum perineal laceration requiring suturing; * have reached 37 gestational weeks; * are over 18 years of age; * had a top birth; * are able to understand the Italian language; * have a consent to participate in the study; Exclusion Criteria: - have received epidural anesthesia within 2 hours prior to delivery; * had an operative birth; * have a psychiatric pathology; * have had a twin birth; * have experienced adverse reactions to any local anesthetic in the past; * hypersensitivity to the active substance or to any of the excipients * Severe disturbances of the cardiac conduction system * Acute non compensated heart failure * Severe arteriopathies * Severe uncontrolled hypertension * Intravascular injections * Septicemia Dysfunction * Infection at the injection site * Kidney failure. Providing for the exclusion of patients with severe renal impairment (estimated GFR \<30 mL / min / 1.73 m2 at the time of screening). * Advanced liver dysfunction * Hyperthyroidism * Acute angle glaucoma * Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or 5 half-lives of the study drug * Any clinical condition that in the investigator's judgment would render the patient unsuitable for the study including, but not limited to, infectious, inflammatory, psychiatric, neurological, cardiological, renal, hepatic, respiratory, diabetes) conditions or laboratory value at clinically meaningful screening that, an investigator's opinion, may present a safety risk, interface with study compliance and follow-up; * have had in pregnancy liver disease including pre-eclampsia.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial (RCT) of superiority, with two parallel treatment arms.\n\nPhase 3 study. Randomized controlled single-center perspective study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label: due to the different methods of administration, the blindness of the obstetrician-gynecological team cannot be guaranteed.'}}, 'enrollmentInfo': {'count': 136, 'type': 'ACTUAL'}}

2023-09-21