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

NovaSure 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. The primary endpoint is the perception of pain during the Novasure®
procedure.
When there is no difference in VAS score between both groups, we only need to
change our method of (para)cervical anesthesia and do not need the special
hysteroscopy instruments (syringes) for performing the fundal anesthesia.
Besides, this would reduce the risk of toxicity and perforation.

To compare a combination of paracervical anesthesia and fundal anesthesia with
paracervical anesthesia only during endometrial ablation.

A double-blind randomized controlled trial

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 fundus (4x1 ml of ropivacaine 2mg/ml).
Women in the controlgroup will receive the same injections with natriumchloride
0.9% instead of ropivacaine.

In case of better pain reduction in the intervention group (combination of
paracervical and fundal anesthesia), women in the control group experience
higher levels of pain (compared to the standard care). We perform a
non-inferiority study, so we expect the same levels of pain in both groups.
Until now, there are only two studies which investigated fundal anesthesia.
Both studies demonstrated that combining a (para)cervical and fundal block
significantly reduces the pain perception. Besides, no major complications or
adverse reactions were described in both studies. In one study, only three
women (10%) experienced a vasovagal response with spontaneous recovery. In the
other study, 12% of the women reported a slight dizziness or light-headedness
(with stable vital parameters) after injection of the fundal block. In our
pilot study (N=10) no adverse effects or complications were reported.

The women fill out a couple of questionnaires (directly before and after the
procedure, and 1, 6 and 24 hours after the procedure), which will take 15
minutes.
If we conclude that fundal anesthesia is not neccessary, this has safety and
economic benefits in the future.