Fundal Block in Pre-menopausal Women to Reduce Pain During Outpatient-based Endometrial Ablation (FUNDAL-PAIN)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the efficacy of a fundal block in reducing women's perception of pain during NovaSure endometrial ablation (EA) in an outpatient-based setting.

Detailed Description
-----------------
The researchers aim to determine whether participants receiving the paracervical and fundal block (experimental group) achieve clinically and statistically significant reductions in self-reported pain during NovaSure EA, as compared to those receiving paracervical block (control group). All women will obtain concurrent procedural sedation. Women's perception of pain will be recorded on a scale from 0 to 10 using the visual analogue scale (VAS). The researchers hypothesize that the participants receiving combined paracervical and fundal block will experience less pain during the active procedure, as compared to those receiving paracervical block alone.

Official Title
-----------------
FUndal Block During NovaSure enDometrial AbLation to Reduce Intraoperative PAIN: A Randomized Controlled Trial

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Xylocaine 1 % and Normal Saline
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abnormal uterine bleeding Pre-menopausal as determined by the presence of menstrual cycles Must have completed their family or have no desire to preserve fertility Uterus and cervix must meet eligibility criteria; based on hysteroscopy exam performed by the physician prior to the ablation procedure Must be a female participant 25-55 years of age Exclusion Criteria: Any uterine characteristics that preclude performing EA Past allergic reactions to local anaesthetic Weight <50kg Submucous fibroids requiring myomectomy Lack of patient consent

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>NovaSure EA with an injection of local anaesthetic into the fundus. Paracervical block and procedural sedation as per usual. | Drug: Xylocaine 1 % and Normal Saline<br>* 3cc aliquots of local anaesthetic will be injected into the right and left cornual regions and centrally in the fundus. This will be achieved by using a flexible hysteroscopic needle.<br>* Other names: Local anaesthetic;|
| Placebo Comparator: Control Group<br>NovaSure EA with an injection of normal saline into the fundus. Paracervical block and procedural sedation as per usual. | Drug: Normal Saline<br>* 3cc aliquots of normal saline will be injected into the right and left cornual regions and centrally in the fundus. This will be achieved by using a flexible hysteroscopic needle.<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative pain | Thirty seconds into the active NovaSure EA procedure, all participants will be asked the same standardized question to rate their pain. The question will be posed by the registered nurse assisting the physician, and the women will score their perception of pain on a scale from 0 to 10 using the VAS. | 30 seconds into active ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Using the VAS, all participants will be asked to rate their pain 1 hour post-procedure. | 1 hour post-procedure | 
| Rescue analgesics/and or sedation | The use of additional rescue analgesics/and or sedation during the active ablation procedure and post-operative period will be recorded and compared between groups. | From time of active ablation procedure to discharge from unit (t = 0 sec to t =  3hrs). | 
| Adverse reactions | Any adverse reactions that occur in response to the fundal injections during and following the procedure will be recorded and compared between groups. | From time of active ablation to discharge from unit ( t= 0 sec to t =  3hrs). | 
| Acceptability of the procedure | The acceptability of the ablation procedure will be evaluated between groups by asking each participant if they would recommend the procedure to a friend. | Post-procedure prior to discharge (t =  3hrs). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abnormal Uterine Bleeding, Endometrial Ablation, NovaSure, Pain