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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: Xylocaine 1 % and Normal Saline; Drug: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 6X3
      • Gynaecology & Pediatric Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; 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; 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.; Other Names: Local anaesthetic
Placebo Comparator: Control Group; NovaSure EA with an injection of normal saline into the fundus. Paracervical block and procedural sedation as per usual.	Drug: Normal 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.; 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).

Collaborators and Investigators

• Sponsor: Saskatchewan Health Authority - Regina Area
• Investigators: Principal Investigator: Darrien Rattray, MD, Saskatchewan Health Authority - Regina Area

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 26, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Abnormal Uterine Bleeding; Endometrial Ablation; NovaSure
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine; Anesthetics, Local
• Other Study ID Numbers: SaskHealthAuthority

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No