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Decreasing Postoperative Pain Following Endometrial Ablation

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Normal Saline
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

30 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Christiana Care Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Intraoperative Total Blood Loss
Amount of operative blood lost measured in milliliters
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.

Secondary Outcome Measures

Occurrence of Intraoperative Complication
This represents any unanticipated complication related to the endometrial ablation.
Postoperative Complication
Any unanticipated complication related to the endometrial ablation.
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.
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 Anti-emetic
Data was collected on any nausea medicine administered following the endometrial ablation.
Time Between Recovery Initiation and Discharge
Time between arrival to the recovery room after surgery and discharge to home

Full Information

First Posted
January 19, 2016
Last Updated
August 25, 2019
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT02660918
Brief Title
Decreasing Postoperative Pain Following Endometrial Ablation
Official Title
Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Christiana Care Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine, Sensorcaine
Intervention Description
Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
Equal volume injection of normal saline with the same paracervical technique
Primary Outcome Measure Information:
Title
Postoperative Pain Score
Description
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
Immediate postoperatively through 8 hours post operation.
Title
Intraoperative Total Blood Loss
Description
Amount of operative blood lost measured in milliliters
Time Frame
Intraoperative
Title
Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge
Description
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
Postoperative
Secondary Outcome Measure Information:
Title
Occurrence of Intraoperative Complication
Description
This represents any unanticipated complication related to the endometrial ablation.
Time Frame
During Surgery
Title
Postoperative Complication
Description
Any unanticipated complication related to the endometrial ablation.
Time Frame
1 Day Postoperative
Title
Postoperative Opioid Administered Following the Procedure But Prior to Discharge.
Description
Narcotic medications administered in the recovery area before the patient was discharged from the Surgicenter.
Time Frame
Predischarge from hospital
Title
Postoperative Toradol
Description
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
Title
Postoperative Anti-emetic
Description
Data was collected on any nausea medicine administered following the endometrial ablation.
Time Frame
Postoperative
Title
Time Between Recovery Initiation and Discharge
Description
Time between arrival to the recovery room after surgery and discharge to home
Time Frame
hours between recovery initiation and discharge

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Klebanoff, MD
Organizational Affiliation
Christiana Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24288154
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.
Results Reference
background
PubMed Identifier
19896596
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.
Results Reference
background
PubMed Identifier
14511961
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.
Results Reference
background

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Decreasing Postoperative Pain Following Endometrial Ablation

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