Decreasing Postoperative Pain Following Endometrial Ablation

NCT ID: NCT02660918

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-03-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure

Control

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: OTHER

Equal volume injection of normal saline with the same paracervical technique

Interventions

Bupivacaine

Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure

Intervention Type: DRUG

Normal Saline

Equal volume injection of normal saline with the same paracervical technique

Intervention Type: OTHER

Other Intervention Names

Marcaine, Sensorcaine

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Jordan Klebanoff

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jordan Klebanoff, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Hospital

Locations

Christiana Care Health System

Newark, Delaware, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24288154 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19896596 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14511961 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

35179

Identifier Type: -

Identifier Source: org_study_id