A randomized controlled trial comparing paracervical block with a combination of paracervical block and fundal anesthesia during endometrial ablation in the outpatient clinic.
- Conditions
- Endometrial ablationNovasureLocal anesthesiaParacervical blockFundal blockEndometriumablatieNovasureLokale anesthesieParacervicaal blockFundusblokkade
- Registration Number
- NL-OMON26448
- Lead Sponsor
- Máxima Medisch Centrum, Veldhoven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 96
Inclusion Criteria
Premenopausal women (≥18 years), ASA classification 1-2, with menorrhagia, who are planned for a NovaSure endometrial ablation under local anesthesia.
Exclusion Criteria
Women younger than 18 years
Women who do not understand Dutch
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the intensity of pain 1 minute into active ablation, using the Visual Analogue Score scale and Numeric Rating scale.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are the intensity of pain during hysteroscopy, cervical dilatation and 1, 6 and 24 hours after the procedure. Furthermore, postoperative use of pain medication, complications, adverse effects and satisfaction will be compared. <br>Impression of pain during the treatment noted by the gynecologist and nurse.