Decreasing Postoperative Pain Following Endometrial Ablation

Not Applicable

Completed

Conditions: Postoperative Pain

Interventions: Other: Normal Saline
Drug: Bupivacaine

Registration Number: NCT02660918

Lead Sponsor: Christiana Care Health Services

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 84

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal Saline	Women undergoing endometrial ablation that meet the eligibility criterial will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Treatment	Bupivacaine	Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure.

Primary Outcome Measures

Name	Time	Method
Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge	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.
Postoperative Pain Score	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
Intraoperative Total Blood Loss	Intraoperative	Amount of operative blood lost measured in milliliters

Secondary Outcome Measures

Name	Time	Method
Postoperative Complication	1 Day Postoperative	Any unanticipated complication related to the endometrial ablation.
Time Between Recovery Initiation and Discharge	hours between recovery initiation and discharge	Time between arrival to the recovery room after surgery and discharge to home
Occurrence of Intraoperative Complication	During Surgery	This represents any unanticipated complication related to the endometrial ablation.
Postoperative Anti-emetic	Postoperative	Data was collected on any nausea medicine administered following the endometrial ablation.
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.	Predischarge from hospital	Narcotic medications administered in the recovery area before the patient was discharged from the Surgicenter.
Postoperative Toradol	Postoperative	Data was collected on whether or not the patient received Toradol following the endometrial ablation. Toradol is a non-narcotic pain medication.