Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

Bnai Zion Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Labor, Induced

Treatments: Other: Placebo; Drug: Topical Analgesia with Lidocaine-Prilocaine cream

Study type: Interventional

Funder types: Other

Identifiers

NCT07288021

0061-23-BNZ

Details and patient eligibility

About

The goal of this RCT is to learn if application of topical anesthetic cream to the perineum and posterior wall of vagina prior to balloon catheter insertion as part of labor induction will reduce pain levels experienced by pregnant individuals.

All participants are 18 or older, carrying a singleton in vertex position and in need of labor induction, are late-preterm or term (34 weeks gestation and onward) and without contraindication to vaginal delivery.

Investigators seek to compare pain levels and patient satisfaction between two groups:

Nulliparous patients, using EMLA or placebo (randomized, double blinded). Multiparous patients, EMLA or placebo.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women scheduled for labor induction with balloon catheter.
• 18 years of age or older.
• Singleton pregnancy with a cephalic presentation.
• ≥ 34 completed gestational weeks.
• Does not participate in any other trial that might affect maternal or fetal/neonatal outcomes.
• No contraindication for vaginal delivery

Exclusion criteria

• Unable or unwilling to provide and sign informed consent forms.
• Known sensitivity to EMLA or placebo substance.
• Known vulvodynia or vaginismus - rendering vaginal examination not possible.
• Any chronic pain syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

EMLA

Experimental group

Treatment:

Drug: Topical Analgesia with Lidocaine-Prilocaine cream

Placebo

Placebo Comparator group

Treatment:

Other: Placebo