Christiana Care Health System
Newark, Delaware, 19713, United States
NCT Number: NCT02660918
To determine whether paracervical injection of long acting local anesthesia decreases postoperative pain following endometrial ablation under general anesthesia.
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Notify Me30 year–55 year
Female
Interventional
Not applicable
Newark, Delaware, 19713, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
Other names: Marcaine, Sensorcaine
Equal volume injection of normal saline with the same paracervical technique
Time frame: Immediate postoperatively through 8 hours post operation.
Pain will be assessed using a 10 point visual analog scale. On the scale 0 represented no pain and 10 represented the highest pain level. Eligibility for analgesia was available for patients who reported pain higher than 5 out of 10 on the scale.
Pain levels were assessed by trained nursing staff blinded to the study. Lower numbers on the 10 point scale represented a positive outcome.
Patients
Time frame: Intraoperative
Amount of operative blood lost measured in milliliters
Time frame: Postoperative
All patients were given 10 tablets of Tylenol with codeine upon discharge for pain. This Outcome measure details the remaining number of tablets after day 1.
Time frame: During Surgery
This represents any unanticipated complication related to the endometrial ablation.
Time frame: 1 Day Postoperative
Any unanticipated complication related to the endometrial ablation.
Time frame: Predischarge from hospital
Narcotic medications administered in the recovery area before the patient was discharged from the Surgicenter.
Time frame: Postoperative
Data was collected on whether or not the patient received Toradol following the endometrial ablation. Toradol is a non-narcotic pain medication.
Time frame: Postoperative
Data was collected on any nausea medicine administered following the endometrial ablation.
Time frame: hours between recovery initiation and discharge
Time between arrival to the recovery room after surgery and discharge to home
Christiana Care Health Services
Other
Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial
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