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Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations

NCT05201313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-09-21

No results posted yet for this study

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 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.

Conditions

  • Vaginal Discharge
  • Perineum; Rupture
  • Analgesia

Interventions

DRUG

Lidocaine Hydrochloride

nebulization of 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm

DRUG

Mepivacaine Injection

subcutaneous / submucosal infiltration depending on the type of perineal tear of 10 ml of 1% mepivacaine hydrochloride

Sponsors & Collaborators

  • Azienda Sanitaria-Universitaria Integrata di Udine

    lead OTHER

Principal Investigators

  • Lorenza Driul, professor · DAME

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2022-07-08
Completion
2022-08-08

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05201313 on ClinicalTrials.gov