Clinical trial NCT02660918: Decreasing Postoperative Pain Following Endometrial Ablation
Official title: Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 84
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Pain Score
timeFrame: Immediate postoperatively through 8 hours post operation.
measure: Intraoperative Total Blood Loss
timeFrame: Intraoperative
measure: Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge
timeFrame: Postoperative
Secondary outcomes:
measure: Occurrence of Intraoperative Complication
timeFrame: During Surgery
measure: Postoperative Complication
timeFrame: 1 Day Postoperative
measure: Postoperative Opioid Administered Following the Procedure But Prior to Discharge.
timeFrame: Predischarge from hospital
measure: Postoperative Toradol
timeFrame: Postoperative
measure: Postoperative Anti-emetic
timeFrame: Postoperative
measure: Time Between Recovery Initiation and Discharge
timeFrame: hours between recovery initiation and discharge
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
affiliation: Christiana Hospital
name: Jordan Klebanoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2013 Nov 29;(11):CD000329. doi: 10.1002/14651858.CD000329.pub2.
citation: Glasser MH, Heinlein PK, Hung YY. Office endometrial ablation with local anesthesia using the HydroThermAblator system: Comparison of outcomes in patients with submucous myomas with those with normal cavities in 246 cases performed over 5(1/2) years. J Minim Invasive Gynecol. 2009 Nov-Dec;16(6):700-7. doi: 10.1016/j.jmig.2009.06.023.
citation: Wallage S, Cooper KG, Graham WJ, Parkin DE. A randomised trial comparing local versus general anaesthesia for microwave endometrial ablation. BJOG. 2003 Sep;110(9):799-807.