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Pericervical Analgesia Versus Analesia With Nitrous Oxide (N2O) in Outpatien Operative Hysteroscopy With Miniresector

Sponsor
Ospedale degli Infermi di Biella (Other)
Overall Status
Recruiting
CT.gov ID
NCT06092541
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The work we want to propose will have the aim of evaluating and comparing the effectiveness of two methods (analgesia with nitrous oxide and pericervical analgesia, excluding the use of paracervical block due to the increased risk of complications reported in the literature in the control of pain caused during Outpatient Operative Hysteroscopy maneuvers with Miniresector.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intervention Group: pericervical anesthesia
  • Other: Nitroux Oxide anesthesia
 N/A

Detailed Description

Pain is the primary cause of hysteroscopy failure. It can be attributed to multiple causes, such as manipulation of the cervical canal , uterine distention due to the liquid distension media used during the procedure , operating procedures on the endometrium (as a possible cause of uterine contraction) , until the release of prostaglandins following manipulation of the cervix and uterine distension.

There are few studies in the literature that have compared the various methods of pain control during the hysteroscopic examination. Among these, Ahmad et al., for example, compared the use of the paracervical block and inhalation anesthesia during hysteroscopy: although both proved to be effective in controlling pain, the paracervical block was associated with a greater number of complications. More recently, Solano et al. they defined how the administration of nitrous oxide was equally effective (but with many more advantages) to the paracervical block with 1% lidocaine in controlling pain during hysteroscopy performed using the Bettocchi hysteroscope.

However, for the purposes of our work it is important to take two aspects into consideration:

  • all the studies in the literature that compared the various pain control methods during hysteroscopy were conducted using the Bettocchi Hysteroscope and not the Miniresector;

  • more in detail, there are no studies comparing the use of nitrous oxide and pericervical analgesia during outpatient operative hysteroscopy with miniresector.

Objective The work we want to propose will have the aim of evaluating and comparing the effectiveness of two methods (analgesia with nitrous oxide and pericervical analgesia, excluding the use of paracervical block due to the increased risk of complications reported in the literature1) in the control of pain caused during Outpatient Operative Hysteroscopy maneuvers with Miniresector.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-blind, randomized clinical pilot study with masked third-party assessment. Patients will be assigned to the two groups (pericervical analgesia / nitrous oxide) through the sealed envelope method.Single-blind, randomized clinical pilot study with masked third-party assessment. Patients will be assigned to the two groups (pericervical analgesia / nitrous oxide) through the sealed envelope method.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The patients, in the database, will be identified as group A and B; Once the study and the compilation of the database have been completed, this will be delivered to the results evaluation team which will therefore be blinded, not being able to recognize whether group A and B belong to control or intervention.
Primary Purpose:
Treatment
Official Title:
Comparison of Efficacy Between Nitrous Oxide (n2o) Analgesia and Pericervical Analgesia in Outpatient Operative Hysteroscopy With Miniresector: a Randomized Clinical Pilot Study
Actual Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Apr 2, 2024
Anticipated Study Completion Date :
Apr 2, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group: pericervical anesthesia

Intervention group: pericervical anesthesia

Drug: Intervention Group: pericervical anesthesia
Patients assigned to the Intervention Group will receive Pericervical anesthesia before performing Hysteroscopy. Specifically, for the administration of pericervical analgesia, Mepivacaine/Lidocaine 1.5% 10/15 ml (max dose 7 mg/kg) will be used and pericervical infiltration will be performed at 0.5 cm depth at 3 and 9 hours.
Other Names:
  • Pericervical Anesthesia

    		•
    Active Comparator: Control group: nitrous oxide anesthesia

    Control group: nitrous oxide anesthesia

    Other: Nitroux Oxide anesthesia
    Patients assigned to the Control Group will receive Nitrous Oxide anesthesia before hysteroscopy
    Other Names:
  • N2O2 Anesthesia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of pain, measured through the Visual Analog Scale -VAS- using Pericervical Analgesia versus Analgesia with Nitrous Oxide in outpatient hysteroscopic surgery with Miniresector [6 months]

      Change From Baseline in Pain Scores on the Visual Analog Scale -VAS- using Pericervical Analgesia versus Analgesia with Nitrous Oxide in outpatient hysteroscopic surgery with Miniresector

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • nulliparous or primiparous women (a previous Spontaneous Vaginal Birth -PS- or a previous Cesarean Section -TC- the latter comparable to nulliparous women as no previous cervical dilation -)

    • age between 25 and 50 years

    Exclusion Criteria:

    • age < 25 or > 50 years

    • multiparity

    • positive history of previous operations on the cervical canal (e.g. conization)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ospedale degli Infermi Biella Italy

    Sponsors and Collaborators

    • Ospedale degli Infermi di Biella

    Investigators

    • Principal Investigator: Bianca Masturzo, MD PhD, Ospedale degli Infermi Biella

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bianca Masturzo, Head of Obstetrics and Gynecology, Ospedale degli Infermi di Biella
    ClinicalTrials.gov Identifier:
    NCT06092541
    Other Study ID Numbers:
    • CE 130/2023
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bianca Masturzo, Head of Obstetrics and Gynecology, Ospedale degli Infermi di Biella
    hysteroscopy
    pain control
    pericervical anesthesia
    nitrous oxide
    Additional relevant MeSH terms:
    Anesthetics

    Study Results

    No Results Posted as of Oct 23, 2023