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

NCT ID: NCT05201313

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2022-08-08

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.

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.

Conditions

Vaginal Discharge; Perineum; Rupture; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lidocaine spray

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

Group Type: EXPERIMENTAL

Lidocaine Hydrochloride

Intervention Type: DRUG

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

mepivacaine infiltration

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

Group Type: ACTIVE_COMPARATOR

Mepivacaine Injection

Intervention Type: DRUG

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

Interventions

Lidocaine Hydrochloride

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

Intervention Type: DRUG

Mepivacaine Injection

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

Intervention Type: DRUG

Other Intervention Names

ECOCAIN; MEPIVACAINA CLORIDRATO

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Sanitaria-Universitaria Integrata di Udine

OTHER

Sponsor Role: lead

Responsible Party

Stefano Restaino

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenza Driul, professor

Role: STUDY_CHAIR

DAME

Locations

ASUFC

Udine, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 38914976 (View on PubMed)

Other Identifiers

0042698/P/GEN/ARCS

Identifier Type: -

Identifier Source: org_study_id