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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Vaginal Discharge; Perineum; Rupture
• Intervention / Treatment: Drug: Lidocaine Hydrochloride; Drug: Mepivacaine Injection

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 treatment of perineal pain with nebulization demonstrates comparable efficacy vs the infiltration of mepivacaine hydrochloride in a population of patients subjected to suturing of postpartum lacerations. Eligible women will be randomly assigned to receive, after wound disinfection and cleansing of bleeding with mild haemostasis:

1. nebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm (experimental group).
2. subcutaneous / submucosal infiltration depending on the type of perineal laceration of 10 ml of 1% mepivacaine hydrochloride (control group).

Since there are no previous published studies, regarding the use of nebulized lidocaine hydrochloride for the suturing of perineal lacerations, the number of puffs chosen was chosen based on what is indicated on the technical data sheet of lidocaine hydrochloride and making use of previous studies in the gynecological field, but with other indications.

The suture will be made once anesthetic efficacy is achieved, as per pharmacological indications. The administration of the anesthetic and the suturing of the lacerations will be performed by the gynecologist or by the gynecology resident who will be working at that time in the delivery room, as is routinely done in our Clinic. The patients will be enrolled consecutively following the order generated by the randomization list itself. By filling in specific pre-set cards, the data will be collected.

Initially, the primary outcome was NRS at the beginning of suturing and NRS at the end of the procedure. In a second moment, the investigators thought it would be better to ensure that adequate analgesia (NRS<4) was achieved for all patients during suturing, rather than varying the dosage of the anesthetic itself. The investigators then decided to reassess pain at successive time points, evaluating it at 0, 2, 4, 12, and 24 hours.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Udine, Italy, 33100
    • ASUFC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lidocaine spray; nebulization 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm	Drug: Lidocaine Hydrochloride; nebulization of 3 puffs of 10 mL Lidocaine hydrochloride 10% spray at a distance of 4-5 cm; Other Names: ECOCAIN
Active Comparator: mepivacaine infiltration; subcutaneous / submucosal infiltration depending on the type of perineal tear of 10 ml of 1% mepivacaine hydrochloride	Drug: Mepivacaine Injection; subcutaneous / submucosal infiltration depending on the type of perineal tear of 10 ml of 1% mepivacaine hydrochloride; Other Names: MEPIVACAINA CLORIDRATO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
need for additional doses (number of additional nebulizations, presence or absence of additional infiltration)	need for an additional dose of nebulization and / or additional infiltration during the suturing of the postpartum perineal laceration	during the suture
final satisfaction, assessed via telephonic interview	satisfaction of the puerpera, assessed through the 30 days-follow up, asking for the patient's opinion regarding postpartum pain and any long-term complications	30 days follow up

Collaborators and Investigators

• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
• Investigators: Study Chair: Lorenza Driul, professor, DAME

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): July 8, 2022
• Study Completion (Actual): August 8, 2022

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: anesthetic; perineal laceration; suturing
• Additional Relevant MeSH Terms: Wounds and Injuries; Vaginal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Rupture; Lacerations; Vaginal Discharge; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Mepivacaine
• Other Study ID Numbers: 0042698/P/GEN/ARCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No