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Bupivacaine Injection for Uterine Conditions

N/A
Waitlist Available
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during hysteroscopy
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two types of local anesthetic for outpatient hysteroscopy to find which is best to reduce pain.

Who is the study for?
This trial is for women over 18 who need an outpatient surgical hysteroscopy to remove polyps or fibroids. It's not suitable for those under 18, unable to rate pain on a visual scale, with contraindications to hysteroscopy, or conditions making outpatient procedures unsafe.
What is being tested?
The study compares two local anesthesia methods during outpatient procedural hysteroscopy: the standard paracervical block and the transcervical instillation. The goal is to find out which method better reduces pain during the procedure.
What are the potential side effects?
Potential side effects from Bupivacaine injection include discomfort at the injection site, numbness beyond treated area, low blood pressure, dizziness, nausea, and in rare cases more serious reactions like seizures or cardiac issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during hysteroscopy
This trial's timeline: 3 weeks for screening, Varies for treatment, and during hysteroscopy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy
Secondary study objectives
Compare the pain experience based on the visual analogue scale between nulliparous and parous patients
Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients
To evaluate the need for an extra intravenous sedative dose.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transcervical blockExperimental Treatment1 Intervention
10cc Bupivacaine 1% through the endocervix using an 17-gauge epidural catheter
Group II: Paracervical blockActive Control1 Intervention
10cc Bupivacaine 1% at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine Injection
2017
Completed Phase 4
~580

Find a Location

Who is running the clinical trial?

Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-MontréalOTHER_GOV
13 Previous Clinical Trials
14,245 Total Patients Enrolled
Ciusss de L'Est de l'Île de MontréalLead Sponsor
78 Previous Clinical Trials
6,173 Total Patients Enrolled
Mélissa Roy, MDStudy DirectorOB-GYN

Media Library

Transcervical block Clinical Trial Eligibility Overview. Trial Name: NCT05967936 — N/A
Uterine Fibroids Research Study Groups: Paracervical block, Transcervical block
Uterine Fibroids Clinical Trial 2023: Transcervical block Highlights & Side Effects. Trial Name: NCT05967936 — N/A
Transcervical block 2023 Treatment Timeline for Medical Study. Trial Name: NCT05967936 — N/A
~112 spots leftby Nov 2025
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