Pain
Conditions
Keywords
Abnormal Uterine Bleeding, Endometrial Ablation, NovaSure, Pain
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.
Interventions
DRUGXylocaine 1 % and Normal Saline
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.
DRUGNormal Saline
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.
Sponsors
Saskatchewan Health Authority - Regina Area
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patient (participant), physician (care provider), recovery nurse (outcomes assessor) and researcher team (investigator) will all be blinded to the intervention. Only the assisting nurse dedicated to procedural setup will be aware of the allocated intervention.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative pain | 30 seconds into active ablation procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 1 hour post-procedure | Using the VAS, all participants will be asked to rate their pain 1 hour post-procedure. |
| Rescue analgesics/and or sedation | From time of active ablation procedure to discharge from unit (t = 0 sec to t = ~3hrs). | 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. |
| Adverse reactions | From time of active ablation to discharge from unit ( t= 0 sec to t = ~3hrs). | Any adverse reactions that occur in response to the fundal injections during and following the procedure will be recorded and compared between groups. |
| Acceptability of the procedure | Post-procedure prior to discharge (t = ~3hrs). | The acceptability of the ablation procedure will be evaluated between groups by asking each participant if they would recommend the procedure to a friend. |
Countries
Canada
Outcome results
None listed