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Completed

NCT Number: NCT06092541

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

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.

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Key information

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale degli Infermi

Biella, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intervention Group: pericervical anesthesia

Drug

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

Nitroux Oxide anesthesia

Other

Patients assigned to the Control Group will receive Nitrous Oxide anesthesia before hysteroscopy

Other names: N2O2 Anesthesia

Primary outcomes

  1. Rate of pain, measured through the Visual Analog Scale 1 (no pain) to 10 (worse pain) using Pericervical Analgesia versus Analgesia with Nitrous Oxide in outpatient hysteroscopic surgery with Miniresector

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ospedale degli Infermi di Biella

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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