Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
ConditionLabor, Induced
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBnai Zion Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women scheduled for labor induction with balloon catheter.
18 years of age or older.
Singleton pregnancy with a cephalic presentation.
≥ 34 completed gestational weeks.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Topical Analgesia with Lidocaine-Prilocaine cream
Drugpatients 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.
Placebo
Other interventionpatients 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: EMLAExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain levels during insertion
Pain levels during insertion of balloon catheter, as experienced by participant and ranked from 1 to 5 \[1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)\].
Time frame
directly after application and insertion of balloon catheter.Secondary outcomes
1
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).
Time frame
6-12 hours2
pain score during removal of catheter
Pain levels during removal of balloon catheter, as experienced by participant and ranked from 1 to 5 \[1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)\].
Time frame
to be asked directly after removal, on a scale of 1-5.3
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).
Time frame
to be asked directly after removal, on a scale of 1-5.4
analgesia during delivery
need and use for medical analgetics during the delivery process, including epidural, dolestion and NO.
Time frame
From time of balloon insertion until the time of delivery, assessed up to 3 days and to be checked immediately after delivery.Other outcomes
1
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).
Time frame
the patient is to be asked by inserting physician directly after insertion, on a scale of 1-5.Sponsors and contacts
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Source ClinicalTrials.gov