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

Saskatchewan Health Authority - Regina Area288 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

288

Conditions

Pain

Interventions

Xylocaine 1 % and Normal SalineDRUG

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.

Normal SalineDRUG

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.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Gynaecology & Pediatric Associates

Regina, Saskatchewan, Canada

Outcomes

Primary Outcomes

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.

Time frame: 30 seconds into active ablation procedure

Secondary Outcomes

Post-operative pain

Using the VAS, all participants will be asked to rate their pain 1 hour post-procedure.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Post-procedure prior to discharge (t = ~3hrs).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.