A randomized controlled trial comparing paracervical block with a combination of paracervical block and fundal anesthesia during endometrial ablation in the outpatient clinic.
Completed
- Conditions
- pain during active endometrial ablation10029903
- Registration Number
- NL-OMON43705
- Lead Sponsor
- Maxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
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
- Women who might want to get pregnant in the future
- Women with low body weight (under 45 kilograms)
- Allergic/intolerance to amides (type of local anesthetic)
- Women suffering from methemoglobinemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pain score during active ablation, using the Faces Pain Scale and Verbal Rating<br /><br>Scale.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Pain scores and pulse rate during hysteroscopy, cervical dilatation and 1, 6<br /><br>and 24 hours after the procedure. 'Overall' pain score directly after the<br /><br>procedure.<br /><br>- Impression of the experienced pain, rated by the gynecologist (by the numeric<br /><br>rating scale, 0-10)<br /><br>- Use of pain medication after the procedure<br /><br>- Adverse effects and complications<br /><br>- Satisfaction about the treatment and the anesthesia </p><br>