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Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy

NCT05967936 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2023-08-01

No results posted yet for this study

Summary

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.

Conditions

  • Myoma;Uterus
  • Polyp Uterus

Interventions

DRUG

Bupivacaine Injection

evaluation of pain by using two different types of local anesthesia

Sponsors & Collaborators

  • Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

    collaborator OTHER_GOV

  • Ciusss de L'Est de l'Île de Montréal

    lead OTHER

Principal Investigators

  • Mélissa Roy, MD · OB-GYN

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-09-01
Completion
2024-12-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05967936 on ClinicalTrials.gov