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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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26448
Enrollment
96
Registered
2015-10-17
Start date
2015-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Endometrial ablation Novasure Local anesthesia Paracervical block Fundal block Endometriumablatie Novasure Lokale anesthesie Paracervicaal block Fundusblokkade

Interventions

In the intervention group, the women receive a intramyometrially injected local anesthetic (ropivacaine 2mg/ml) in the uterine fundus after the placement of an extensive paracervical block. In the con

Sponsors

Máxima Medisch Centrum, Veldhoven
Lead Sponsor

Eligibility

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
The primary outcome is the intensity of pain 1 minute into active ablation, using the Visual Analogue Score scale and Numeric Rating scale.

Secondary

MeasureTime frame
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. Impression of pain during the treatment noted by the gynecologist and nurse.

Contacts

Public ContactImke Reinders

Máxima Medisch Centrum

reindersimke@gmail.comphonenumber: +31621946368

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)