Hysteroscopy
Conditions
Keywords
hysteroscopy, pain control, pericervical anesthesia, nitrous oxide
Brief summary
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.
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 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.
Interventions
DRUGIntervention 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.
OTHERNitroux Oxide anesthesia
Patients assigned to the Control Group will receive Nitrous Oxide anesthesia before hysteroscopy
Sponsors
Ospedale degli Infermi di Biella
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
Italy
Outcome results
None listed