Comparing Lidocaine-Prilocaine Cream and Lidocaine Injection for First-Degree Perineal Tear Repair in Women

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What is this study about?

This clinical trial is focused on studying the treatment of first-degree perineal tears, which are small tears that can occur in the area between the vagina and anus during childbirth. The study will compare two different methods of pain relief used during the repair of these tears. One method involves using a cream called EMLA, which contains two active substances, lidocaine and prilocaine. This cream is applied directly to the skin. The other method uses an injection of lidocaine hydrochloride, which is a solution injected into the area to numb it.

The purpose of the study is to compare how effective these two methods are in managing pain during the repair of the tear and in the two hours following childbirth. Participants in the study will receive either the cream or the injection, and their pain levels will be monitored and recorded. The study aims to provide insights into which method offers better pain relief for women experiencing first-degree perineal tears.

Throughout the study, participants will be observed to assess their pain levels and the characteristics of the tear, as well as other factors related to childbirth and the postpartum period. This includes monitoring the onset of labor, any alternative pain management therapies used, and the practice of skin-to-skin contact with the newborn. The study will also consider the characteristics of the newborn, such as weight and sex, and the mother’s age and number of previous births. The trial is expected to run until May 2025.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria: having a single natural delivery, being at least 37 weeks pregnant, experiencing a first-degree perineal tear that requires suturing, and being a postpartum woman aged 18 or older.

2 randomization

Participants are randomly assigned to one of two groups. One group receives a topical cream containing lidocaine and prilocaine (Emla), while the other group receives an injection of 2% lidocaine solution.

3 administration of anesthetic

For the group using the cream, the lidocaine-prilocaine cream is applied topically to the affected area. For the group receiving the injection, the 2% lidocaine solution is administered through infiltration at the site of the tear.

4 repair of perineal tear

The perineal tear is repaired using sutures. The effectiveness of the anesthetic is evaluated during this process to assess pain levels.

5 pain assessment

Pain is measured using a Visual Analogue Scale (VAS), which allows participants to express their pain levels during the administration of the anesthetic, the repair procedure, and the two hours following delivery.

6 post-procedure observation

Participants are observed for two hours after delivery. During this time, factors such as the characteristics of the tear, childbirth, postpartum experience, and newborn details are recorded.

Who Can Join the Study?

  • The patient must have had a single eutocic delivery, which means a normal vaginal birth without complications.
  • The pregnancy must have lasted 37 weeks or more, which is considered full-term.
  • The patient must have a first-degree laceration or tear that needs stitching. This is a small tear in the skin and tissue around the vaginal opening.
  • The patient must be a woman who is 18 years old or older and has recently given birth.

Who Cannot Join the Study?

  • Participants must not have any allergies to lidocaine. Lidocaine is a medicine used to numb a specific area of the body.
  • Participants should not have any other medical conditions that could interfere with the study. This means any health issues that might affect the results or safety of the study.
  • Participants must not be taking any medications that could interact with lidocaine. Some medicines can change how lidocaine works or increase the risk of side effects.
  • Participants should not have any infections or skin conditions in the area where the medicine will be applied. This is to ensure the safety and effectiveness of the treatment.
  • Participants must not have a history of severe reactions to local anesthetics. Local anesthetics are medicines used to numb a small part of the body.
  • Participants should not be involved in another clinical trial at the same time. Being in more than one study can affect the results and safety of both studies.

Where you can join this trial?

Verified and Recommended Sites

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Other Sites

Site Name City Country Status
Hospital Universitario De La Plana Villarreal Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
17.06.2024

Trial locations

Lidocaine-Prilocaine Cream (Emla) is a topical anesthetic cream used to numb the skin. In this trial, it is applied to the area of a first-degree perineal tear to reduce pain during the repair process. The cream works by blocking nerve signals in the body, providing pain relief without the need for an injection.

2% Lidocaine Infiltration is an injectable form of anesthesia used to numb a specific area of the body. In this trial, it is injected into the area of a first-degree perineal tear to provide pain relief during the repair process. The injection works quickly to block nerve signals, helping to manage pain effectively.

First-degree perineal laceration – This condition occurs when there is a minor tear in the perineal area, which is the region between the vaginal opening and the anus. It typically happens during childbirth as the baby passes through the birth canal. The tear involves only the skin and the tissue just beneath it, without affecting the muscles. Women may experience mild discomfort or pain, especially during activities such as sitting or walking. The healing process usually occurs naturally over time, with the body repairing the affected tissue. Proper care and hygiene are important to prevent any potential complications during recovery.

Trial ID:
2024-512728-12-00
Protocol code:
DES-26-E(C)A
Trial Phase:
Therapeutic confirmatory (Phase III)

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