Status:
COMPLETED
Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations
Lead Sponsor:
Azienda Sanitaria-Universitaria Integrata di Udine
Conditions:
Vaginal Discharge
Perineum; Rupture
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 lacerat...
Detailed Description
The study aims to compare the effectiveness of pain treatment during the suturing of postpartum perineal lacerations with lidocaine spray vs skin infiltration. The hypothesis of the study is that the ...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2022
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT05201313
Start Date
January 20 2022
End Date
August 8 2022
Last Update
September 21 2023
Active Locations (1)
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1
ASUFC
Udine, Italy, 33100