Decreasing Postoperative Pain Following Endometrial Ablation



Status:Completed
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:30 - 55
Updated:5/4/2017
Start Date:April 2016
End Date:March 2017

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Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial

To determine whether paracervical injection of long acting local anesthesia decreases
postoperative pain following endometrial ablation under general anesthesia.

Destruction of the endometrial lining to control bothersome uterine bleeding has been
implemented since 1937. Currently there are various different 'second generation' energy
sources to avert such bleeding, five of which are now approved in the United States. These 5
second generation devices include: Thermachoice/Cavaterm, which use high temperature fluid
within a balloon; Microsulis, which applies microwaves; Novasure, which uses bipolar energy;
Hydrothermablator, which uses free fluid at high temperatures; ELITT, which uses laser
thermotherapy; and HerOption, which uses cryoablation. Patient selection for endometrial
ablation is crucial, as it is intended for premenopausal women with normal uterine cavities
and no desire for future fertility that are affected by heavy menstrual bleeding. Since the
introduction of the initial 'second generation' device in 1997 these modalities have
overtaken the industry mostly due to their ease of use and shorter operative times.
Regardless, a Cochrane review finds insufficient evidence to prove superiority of these
newer modalities over the traditional 'gold standard' resectoscopic technique.

Endometrial ablation has been demonstrated in a variety of settings including outpatient
surgical centers as well as physician's offices. Evidence suggests that microwave
endometrial ablation under local anesthesia is a safe and acceptable practice. Very often,
when endometrial ablation is performed as an outpatient procedure, patients are
pre-medicated and then receive a paracervical injection of local anesthesia to control pain
intraoperatively. When endometrial ablations are performed as an outpatient procedure
through a surgical center, a variety of anesthesia techniques are employed depending on the
infrastructure and human and institutional resources available. These techniques may vary
from conscious sedation to general anesthesia, all of which have been proven to be
acceptable methods.

In this center endometrial ablations are performed as an outpatient procedure under general
anesthesia with a variety of induction techniques and intraoperative pain management
practices. According to physician preference, patients may receive an additional
paracervical injection of local anesthetic before the procedure, immediately after, or not
at all. To date, there are no studies evaluating the efficacy of local anesthetic in
addition to general anesthesia for patients receiving endometrial ablation to guide
physician practice. The purpose of this study is to evaluate the efficacy of local
anesthetic, in addition to general anesthesia, in our large, community-based patient
population, in meaningfully decreasing postoperative pain.

Inclusion Criteria:

- Premenopausal women

- English as primary language

- undergoing outpatient endometrial ablation at the Christiana Hospital Surgical Center

- Indication of menorrhagia

- Inication of abnormal uterine bleeding

- Indication of thickened endometrium.

Exclusion Criteria:

- Known malignancy

- weight less than 50 Kg

- amide allergy

- history of chronic pain

- cardiac arrhythmia

- dilaudid/codeine allergy

- history of opioid use

- inability to take opioids by mouth

- uterine anomaly

- previous endometrial ablation

- primary language other than English.
We found this trial at
1
site
Newark, Delaware 19713
Phone: 302-733-1042
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Newark, DE
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