Authorised Therapeutic use (Phase IV) First-dregree perineal laceration

A randomized clinical trial to compare topical lidocaine-prilocaine cream (Emla) versus 2% lidocaine infiltration to first-degree perineal tears repair

EU CTIS ID: 2024-512728-12-00

What this study is testing

Compare the efficacy of injected versus topical lidocaine (EMLA) administration in women with first-degree perineal tear to evaluate pain, both in administration of the anesthetic as well as in the repair of perineal tissue and in the two hours after delivery.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Single eutocic delivery.
  • Gestational age greater than or equal to 37 weeks
  • Presence of first degree laceration/tear requiring suturing
  • Postpartum woman of age greater than or equal to 18 years

You likely can't join if

  • Administration of epidural analgesia.
  • Adverse reactions to any local anesthetic in the past
  • Infection at the site of anesthetic administration.
  • Heart, kidney or liver disease
  • Denial of participation in the study
  • Language barrier. Woman with cognitive deficit or any other mental, physical or social situation that makes it difficult understanding of the study
See the full eligibility criteria
Who can join
  • Single eutocic delivery.
  • Gestational age greater than or equal to 37 weeks
  • Presence of first degree laceration/tear requiring suturing
  • Postpartum woman of age greater than or equal to 18 years
What rules you out
  • Administration of epidural analgesia.
  • Adverse reactions to any local anesthetic in the past
  • Infection at the site of anesthetic administration.
  • Heart, kidney or liver disease
  • Denial of participation in the study
  • Language barrier. Woman with cognitive deficit or any other mental, physical or social situation that makes it difficult understanding of the study
  • Woman with cognitive deficit or any other mental, physical or social situation that makes understanding the study difficult.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.