Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy

July 20, 2023 updated by: Ciusss de L'Est de l'Île de Montréal

A Prospective Randomized Study Comparing Different Types of Local Anesthesia in Outpatient Procedural Hysteroscopy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a multicentric prospective randomized trial, single-blinded, that compares two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.

The population studied will consist in adult women with indication of an outpatient surgical hysteroscopy (myomectomy or polypectomy). Every one of them will be invited to participate the day of their procedure. In the outpatient hysteroscopy clinic, the investigators will verify inclusion and exclusion criteria, explain the objectives of the study, collect data and obtain the patient's consent.

The sample size is 242 patients (121 in each group). The study will be performed in two different centers:

  • Integrated University Health Center and Social Services of the East of the Island of Montreal
  • Integrated University Health Center and social services of the South Center of the Island of Montreal

Right before each procedure the patients will be randomized through anonymous and alternized enveloppes that will be distributed in each center, to either receive paracervical or transcervical anesthesia before hysteroscopy.

Each patient will receive a pre-established dose of sedative before the procedure, according to their weight: Fentanyl 0,5 mcg/kg IV and Midazolam 0,02 mg/kg. The subsequent doses will be noted.

Under sedation, with the patient in lithotomy position, a medium size speculum will be inserted. The vagina will be disinfected with chlorhexidine and the anterior lip of the cervix will be gripped with a Pozzi forceps.

According to previous randomization, each patient will receive one of the following alternatives of local anesthesia:

  • Group A: Paracervical 10cc Bupivacaine 1%, without epinephrine, at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).
  • Group B: Transcervical (uterine) 10cc Bupivacaine 1% through the endocervix using an 17-Gauge epidural catheter

During the procedure (T1), the nurse will be in charge to fill the scale (to avoid bias). The patients will be given a Visual Analogue Scale (VAS) to fill 15 minutes after the procedure (before discharge), to assess pain.

For each group the investigators will calculate the average rate of pain according to the Visual Analogue Scale during and immediately after the procedure (15 minutes). The investigators will subdivide each group into pre and postmenopausal women and into nulliparous and parous women and compare their Visual Analogue Scale as well.

Statistical analysis will be performed to compare results.

Study Type

Interventional

Enrollment (Estimated)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal-Est, Quebec, Canada, H1T 2M4
        • CIUSSS de l'Est de l'Ile de Montréal
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paz Garcia, MD
        • Principal Investigator:
          • Mélissa Roy, MD
        • Principal Investigator:
          • Janey Fang, MD
        • Sub-Investigator:
          • Chantal Rivard, MD
        • Sub-Investigator:
          • Émilie Hudon, MD
        • Sub-Investigator:
          • Émilie Gorak, MD
        • Sub-Investigator:
          • Mik Gangal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients
  • 18 years of age or older
  • Indication of outpatient surgical hysteroscopy for polypectomy and myomectomy

Exclusion Criteria:

  • Women under 18 years old
  • Unable to understand how to score a visual analog scale pain score
  • Hysteroscopy contraindication
  • Patients with medical history or current status that makes outpatient procedure usafe

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paracervical block
10cc Bupivacaine 1% at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).
Drug: Bupivacaine Injection
evaluation of pain by using two different types of local anesthesia
Other Names:
  • evaluation of pain by using two different types of local anesthesia
Experimental: Transcervical block
10cc Bupivacaine 1% through the endocervix using an 17-gauge epidural catheter
Drug: Bupivacaine Injection
evaluation of pain by using two different types of local anesthesia
Other Names:
  • evaluation of pain by using two different types of local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy
Time Frame: during hysteroscopy
comparing 10 point visual analogue scale (from 0 to 10 points) between two groups of patients recieving Bupivacaine administrated through a paracervical block versus a transcervical block
during hysteroscopy
To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy
Time Frame: 15 minutes post hysteroscopy
comparing 10 point visual analogue scale (from 0 to 10 points) between two groups of patients recieving Bupivacaine administrated through a paracervical block versus a transcervical block
15 minutes post hysteroscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients
Time Frame: during hysteroscopy
Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients
during hysteroscopy
Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients
Time Frame: 15 minutes post hysteroscopy
Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients
15 minutes post hysteroscopy
Compare the pain experience based on the visual analogue scale between nulliparous and parous patients
Time Frame: during hysteroscopy
Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients
during hysteroscopy
Compare the pain experience based on the visual analogue scale between nulliparous and parous patients
Time Frame: 15 minutes post hysteroscopy
Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients
15 minutes post hysteroscopy
To evaluate the need for an extra intravenous sedative dose.
Time Frame: during hysteroscopy
Number of patients who demand an extra dose of sedative during hysteroscopy
during hysteroscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Collaborators

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

Investigators

  • Study Director: Mélissa Roy, MD, OB-GYN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-12-2023-3238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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