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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | NovaSure EA with an injection of local anaesthetic into the fundus. Paracervical block and procedural sedation as per usual. |
|
| Control Group | Placebo Comparator | NovaSure EA with an injection of normal saline into the fundus. Paracervical block and procedural sedation as per usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylocaine 1 % and Normal Saline | Drug | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darrien Rattray, MD | Saskatchewan Health Authority - Regina Area | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynaecology & Pediatric Associates | Regina | Saskatchewan | S4S 6X3 | Canada |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014592 | Uterine Hemorrhage |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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.
|
| Normal Saline | Drug | 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. |
|
|
| 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). |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |