Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE) (TOLERANCE)

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.

Study Overview

• Status: Recruiting
• Conditions: Labor, Induced
• Intervention / Treatment: Drug: Topical Analgesia with Lidocaine-Prilocaine cream; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dafna Ben Yehuda Raz, MD, resident doctor; Phone Number: +97248359366; Email: dafna.ben-yehuda@b-zion.org.il
• Study Contact Backup: Name: Inna Bleicher, MD, MFM specialist; Phone Number: +97248359366; Email: inna.bleicher@b-zion.org.il

Study Locations

• Israel
  • Haifa, Israel, 3339419
    • Recruiting
    • Bnai Zion Medical Center
    • Contact: Dafna Ben Yehuda Raz, MD; Phone Number: +97248359366; Email: dafna.ben-yehuda@b-zion.org.il
    • Principal Investigator: Dafna Ben Yehuda Raz, MD, OBGYN resident

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 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.
Experimental: EMLA	Drug: Topical Analgesia with Lidocaine-Prilocaine cream; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesia while with balloon catheter	need for medical analgetics while with balloon catheter, to be checked by analgetics given by nursing staff while the patient is with the balloon cathether in place - a dichotomic variable (yes/no).	6-12 hours
pain score during removal of catheter	Pain levels during removal 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)].	to be asked directly after removal, on a scale of 1-5.
willingness to undergo cervical ripening with balloon catheter in the future	willingness to undergo cervical ripening with balloon catheter in the future, on a scale of 1-5 (1- no, not under any circumstances; 2 - only if no other option exists; 3 - ambivalent; 4 - yes, but with concern; 5 - yes, no problem).	to be asked directly after removal, on a scale of 1-5.
analgesia during delivery	need and use for medical analgetics during the delivery process, including epidural, dolestion and NO.	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	mode of delivery - vaginal, operative vaginal of cesarean delivery	at delivery
neonatal weight	neonatal weight in grams and percentile according to birth weight curves	immediately after delivery
APGAR [Appearance (color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration (breathing)] score	APGAR scores at 1, 5 and 10 minutes of life of newborn, as given by midwife/doctor present at the time. higher values on this score reflect a better outcome.	up to 10 minutes after delivery
cord blood gas	cord blood gas levels, the first measurement taken after birth and up to 10 minutes after delivery.	up to 10 minutes after delivery
Neonatal Intensive Care Unit (NICU) admission	NICU admission of newborn within first week of life	from delivery and up to 1 week
neonatal infection	neonatal infection or suspicion of during birth hospitalization	1st week after delivery
duration of insertion procedure	duration of insertion of catheter procedure	balloon insertion duration, estimated as up to 20 minutes
difficulty of insertion	difficulty of insertion of catheter, as described by inserting physician	to be reported by inserting doctor immediately after insertion procedure is completed, estimated up to 20 minutes.
obstetric trauma	presence of, and degree, of perineal lacerations	up to an hour after delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction After Balloon Catheter Insertion	satisfaction of participant from insertion of balloon catheter, as ranked by participant on a scale of 1-5 (1 - completely unhappy; 2 - slightly unhappy; 3 - ambivalent; 4 - mildly pleased; 5 - very pleased).	the patient is to be asked by inserting physician directly after insertion, on a scale of 1-5.

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 26, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: pain; balloon catheter; induction; EMLA; Lidocaine/prilocaine
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anesthesia and Analgesia; Analgesia
• Other Study ID Numbers: 0061-23-BNZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes