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

Pain Clinical Trial

— FUNDAL-PAIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04249063
• Other study ID #: SaskHealthAuthority
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: June 2023

Study information

• Verified date: April 2023
• Source: Saskatchewan Health Authority - Regina Area
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 288
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Gynaecology & Pediatric Associates	Regina	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
Saskatchewan Health Authority - Regina Area

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative pain	Using the VAS, all participants will be asked to rate their pain 1 hour post-procedure.	1 hour post-procedure
Secondary	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).
Secondary	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).
Secondary	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).