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

Ospedale degli Infermi di Biella

Status: Completed

Conditions: Hysteroscopy

Treatments: Other: Nitroux Oxide anesthesia; Drug: Intervention Group: pericervical anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06092541

CE 130/2023

Details and patient eligibility

About

This research 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.

Full 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 this research 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 This clinical trial 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.

Enrollment: 50 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Intervention group: pericervical anesthesia

Experimental group

Description:

Intervention group: pericervical anesthesia

Treatment:

Drug: Intervention Group: pericervical anesthesia

Control group: nitrous oxide anesthesia

Active Comparator group

Description:

Control group: nitrous oxide anesthesia

Treatment:

Other: Nitroux Oxide anesthesia