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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.


- candidate number22980
- NTR NumberNTR5634
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-okt-2015
- Secondary IDs15.110. METC Maxima Medisch Centrum
- Public TitleA randomized controlled trial comparing paracervical block with a combination of paracervical block and fundal anesthesia during endometrial ablation in the outpatient clinic.
- Scientific TitleA randomized controlled trial comparing paracervical block with a combination of paracervical block and fundal anesthesia during endometrial ablation in the outpatient clinic.
- ACRONYM
- hypothesisWe perform this randomized trial to test the hypothesis that a combination of paracervical anesthesia and fundal anesthesia is not superior to paracervical anesthesia only.
- Healt Condition(s) or Problem(s) studiedEndometrium, Ablation therapy
- Inclusion criteriaPremenopausal women (≥18 years), ASA classification 1-2, with menorrhagia, who are planned for a NovaSure endometrial ablation under local anesthesia.
- Exclusion criteriaWomen 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2015
- planned closingdate31-okt-2016
- Target number of participants54
- InterventionsIn 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 control group, women receive the same paracervical block and in the uterine fundus, they get injections with natriumchloride 0.9% instead of ropivacaine.
- Primary outcomeThe primary outcome is the intensity of pain 1 minute into active ablation, using the Visual Analogue Score scale.
- Secondary outcomeSecondary 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.
- TimepointsThe women will receive questionnaires to record pain scores and use of pain medication 1, 6 and 24 hours after the procedure. 6 weeks after the procedure the women fill out a questionnaire about adverse effects and satisfaction.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Imke Reinders
- CONTACT for SCIENTIFIC QUERIESDr. Marlies Bongers
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center
- Publications
- Brief summaryNovaSure endometrial ablation can be performed in an outpatient setting under local anesthesia or in day-care setting with general or spinal anesthesia. During the procedure under local anesthesia, women experience high levels of pain. Despite the knowledge that pain is the primary reason for failing to complete gynaecological procedures, we still perform the NovaSure procedure under local anesthesia because the ablation and pain experience takes less than two minutes. The advantages of a procedure under local anesthesia are the reduction of anesthetic risks, shorter hospital stay and recovery time, reduction of operating room utilization and the associated costs.
Two studies showed a reduced pain experience when combining a paracervical block with hysteroscopically guided local anesthesia of the uterine fundus. Since we know this method, we introduced it in our clinic. We noted that women experience less pain, but in our opinion it is not due to the fundal anesthesia. Compared to our old protocol, not only the addition of the anesthetic in the uterine fundus has changed. We use a more extensive paracervical block as well. In our opinion, it is more plausible that the extensive paracervical block causes the decrease in VAS score. Therefore we propose a randomized controlled trial in which this extensive paracervical block is compared to a combination of the same paracervical block and fundal block.
- Main changes (audit trail)
- RECORD17-okt-2015 - 27-feb-2016


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