NCT04249063

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Saskatchewan Health Authority - Regina Area · Academic / Other
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-01-18
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2020-01-30
• Last updated: 2023-05-03

Locations

1 site across 1 country: Canada