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

NCT05201313 | Completed Phase 3

• 1 other identifier: 0042698/P/GEN/ARCS
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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 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

Keywords

perineal laceration; suturing; anesthetic

Outcome Measures

Primary Outcomes (5)

• NRS 2

  numeric rating scale for pain (0=no pain-10=maximum pain)

  At 2 hours after delivery

• NRS 4

  numeric rating scale for pain (0=no pain-10=maximum pain)

  At 4 hours after delivery

• NRS 12

  numeric rating scale for pain (0=no pain-10=maximum pain)

  At 12 hours after delivery

• NRS 24

  numeric rating scale for pain (0=no pain-10=maximum pain)

  At 24 hours after delivery

• NRS o

  numeric rating scale for pain (0=no pain-10=maximum pain)

  during suturing

Secondary Outcomes (2)

• need for additional doses (number of additional nebulizations, presence or absence of additional infiltration)

  during the suture

• final satisfaction, assessed via telephonic interview

  30 days follow up

Study Arms (2)

lidocaine spray

EXPERIMENTAL

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

Drug: Lidocaine Hydrochloride

mepivacaine infiltration

ACTIVE COMPARATOR

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

Drug: Mepivacaine Injection

Interventions

Lidocaine Hydrochloride DRUG

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

Also known as: ECOCAIN

lidocaine spray

Mepivacaine Injection DRUG

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

Also known as: MEPIVACAINA CLORIDRATO

mepivacaine infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• \- 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
• Advanced liver dysfunction
• Hyperthyroidism

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (1)

ASUFC

Udine, 33100, Italy

Location

Related Publications (1)

• Restaino S, Degano M, Rizzante E, Battello G, Paparcura F, Biasioli A, Arcieri M, Filip G, Vetrugno L, Dogareschi T, Bove T, Petrillo M, Capobianco G, Vizzielli G, Driul L; LISPRAY Group. Lidocaine spray vs mepivacaine local infiltration for suturing 1st/2nd grade perineal lacerations: a randomised controlled non-inferiority trial. BMC Pregnancy Childbirth. 2024 Jun 24;24(1):439. doi: 10.1186/s12884-024-06640-7.

  PMID: 38914976 DERIVED

MeSH Terms

Conditions

Vaginal Discharge; Rupture; Agnosia

Interventions

Lidocaine; Mepivacaine

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lorenza Driul, professor

  DAME

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label: due to the different methods of administration, the blindness of the obstetrician-gynecological team cannot be guaranteed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial (RCT) of superiority, with two parallel treatment arms. Phase 3 study. Randomized controlled single-center perspective study.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 21, 2022
• Study Start: January 20, 2022
• Primary Completion: July 8, 2022
• Study Completion: August 8, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)