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

Saskatchewan Health Authority

Status: Active, not recruiting

Conditions: Pain

Treatments: Drug: Normal Saline; Drug: Xylocaine 1 % and Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04249063

SaskHealthAuthority

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 estimated patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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288 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

NovaSure EA with an injection of local anaesthetic into the fundus. Paracervical block and procedural sedation as per usual.

Treatment:

Drug: Xylocaine 1 % and Normal Saline

Control Group

Placebo Comparator group

Description:

NovaSure EA with an injection of normal saline into the fundus. Paracervical block and procedural sedation as per usual.

Treatment:

Drug: Normal Saline