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A randomized controlled trial comparing paracervical block with a combination of paracervical block and fundal anesthesia during endometrial ablation in the outpatient clinic.

A randomized controlled trial comparing paracervical block with a combination of paracervical block and fundal anesthesia during endometrial ablation in the outpatient clinic. - Local fundal anesthesia during endometrial ablation (RCT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43705
Enrollment
84
Registered
2015-11-25
Start date
2015-12-07
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain during active endometrial ablation

Interventions

All patients will be anesthetized with the same paracervical block. Women in the intervention group wil receive hysteroscopically guided, intramyometrially injected local anesthesia in the uterine f

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Pain score during active ablation, using the Faces Pain Scale and Verbal Rating Scale.

Secondary

MeasureTime frame
- Pain scores and pulse rate during hysteroscopy, cervical dilatation and 1, 6 and 24 hours after the procedure. 'Overall' pain score directly after the procedure. - Impression of the experienced pain, rated by the gynecologist (by the numeric rating scale, 0-10) - Use of pain medication after the procedure - Adverse effects and complications - Satisfaction about the treatment and the anesthesia

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)