~94 spots leftby Apr 2026

Bupivacaine Injection for Uterine Conditions

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Ciusss de L'Est de l'Île de Montréal
No Placebo Group

Trial Summary

What is the purpose of this trial?

Hysteroscopy is a minimally invasive, diagnostic and therapeutic gynecological surgical technique and the gold standard in the study of the uterine cavity. Thanks to the decrease in the diameter of hysteroscopes and to the vaginoscopic approach, anesthesia is no longer necessary in diagnostic hysteroscopy. Nevertheless, in operative hysteroscopy, given the instrumentalization and the need of cervical dilation, the use of local anesthesia, with or without sedation, is recommended. The different alternatives described in the literature are the following: 1. Cervical/ intracervical block: injection of local anesthetic into the four quadrants of the cervix. 2. Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5 and 7 o'clock positions. 3. Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via catheter through the cervix and into the uterine cavity. 4. Topical cervical anesthesia: application of local anesthetic in gel or spray to the cervix. To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a prospective multicentric study that compare two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.

Eligibility Criteria

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.

Inclusion Criteria

I am a woman aged 18 or older.
I am scheduled for an outpatient surgery to remove polyps or fibroids from my uterus.

Exclusion Criteria

I am a woman under 18 years old.
Unable to understand how to score a visual analog scale pain score
Hysteroscopy contraindication
See 1 more

Treatment Details

Interventions

  • Paracervical Block (Local Anesthesia)
  • Transcervical Block (Local Anesthesia)
Trial OverviewThe 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.
Participant Groups
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).

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
CIUSSS de l'Est de l'Île de MontréalMontréal-Est, Canada
Loading ...

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-MontréalCollaborator

References