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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Efficacy Between Nitrous Oxide (n2o) Analgesia and Pericervical Analgesia in Outpatient Operative Hysteroscopy With Miniresector: a Randomized Clinical Pilot Study

Conditions
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Hysteroscopy

Intervention / Treatment
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* Drug: Intervention Group: pericervical anesthesia
* Other: Nitroux Oxide anesthesia


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group: pericervical anesthesia<br>Intervention group: pericervical anesthesia | Drug: Intervention Group: pericervical anesthesia<br>* 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.<br>* Other names: Pericervical Anesthesia;|
| Active Comparator: Control group: nitrous oxide anesthesia<br>Control group: nitrous oxide anesthesia | Other: Nitroux Oxide anesthesia<br>* Patients assigned to the Control Group will receive Nitrous Oxide anesthesia before hysteroscopy<br>* Other names: N2O2 Anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of pain, measured through the Visual Analog Scale -VAS- using Pericervical Analgesia versus Analgesia with Nitrous Oxide in outpatient hysteroscopic surgery with Miniresector | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysteroscopy, pain control, pericervical anesthesia, nitrous oxide