Decreasing Postoperative Pain Following Endometrial Ablation

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

Detailed Description
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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.

Official Title
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Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Drug: Bupivacaine<br>* Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure<br>* Other names: Marcaine, Sensorcaine;|
| Placebo Comparator: Control<br>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. | Other: Normal Saline<br>* Equal volume injection of normal saline with the same paracervical technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain Score | 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 | Immediate postoperatively through 8 hours post operation. | 
| Intraoperative Total Blood Loss | Amount of operative blood lost measured in milliliters | Intraoperative | 
| Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge | 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 | 

Secondary Outcome Measures

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