Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)

NCT07288021 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 0061-23-BNZ
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor, Induced

Keywords

induction; balloon catheter; EMLA; Lidocaine/prilocaine; pain

Outcome Measures

Primary Outcomes (1)

• Pain levels during insertion

  Pain levels during insertion of balloon catheter, as experienced by participant and ranked from 1 to 5 \[1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)\].

  directly after application and insertion of balloon catheter.

Secondary Outcomes (13)

• analgesia while with balloon catheter

  6-12 hours

• pain score during removal of catheter

  to be asked directly after removal, on a scale of 1-5.

• willingness to undergo cervical ripening with balloon catheter in the future

  to be asked directly after removal, on a scale of 1-5.

• analgesia during delivery

  From time of balloon insertion until the time of delivery, assessed up to 3 days and to be checked immediately after delivery.

• mode of delivery

  at delivery

Other Outcomes (1)

• Participant Satisfaction After Balloon Catheter Insertion

  the patient is to be asked by inserting physician directly after insertion, on a scale of 1-5.

Study Arms (2)

EMLA

EXPERIMENTAL

Drug: Topical Analgesia with Lidocaine-Prilocaine cream

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Topical Analgesia with Lidocaine-Prilocaine cream DRUG

patients allocated to \'EMLA\' arm will receive topical analgesia cream prior to speculum insertion, as part of the administration of balloon catheter insertion process. 3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made to allow for maximal analgesic affect.

EMLA

Placebo OTHER

patients allocated to \'Placebo\' arm will receive lubrication with placebo cream prior to speculum insertion, as part of the administration of balloon catheter insertion process. 3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women scheduled for labor induction with balloon catheter.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, 3339419, Israel

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

Dafna Ben Yehuda Raz, MD, resident doctor

CONTACT

+97248359366; dafna.ben-yehuda@b-zion.org.il

Inna Bleicher, MD, MFM specialist

CONTACT

+97248359366; inna.bleicher@b-zion.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both creams (EMLA and placebo) are specially made in similar containers, labeled as A and B. Head of pharmacy in the study's medical center alone is aware which is EMLA or placebo. Both substances are of similar smell, texture and color.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2025
• First Posted: December 17, 2025
• Study Start: February 5, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-10

Locations

IL (1)