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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes post hysteroscopy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 minutes post hysteroscopy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes post hysteroscopy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy

Secondary outcome measures

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.

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

Do I qualify?Apply below to find out

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

9 Previous Clinical Trials

4,005 Total Patients Enrolled

Ciusss de L'Est de l'Île de MontréalLead Sponsor

70 Previous Clinical Trials

5,318 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible to enroll in this trial?

"As indicated on clinicaltrials.gov, this medical trial is not in the process of recruiting patients at present. The study was first made public on September 1st 2023 and last updated July 20th 2023. Fortunately, there are 42 other ongoing studies that currently need participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy

2023. "Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05967936.

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