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To determine whether paracervical injection of long acting local anesthesia decreases postoperative pain following endometrial ablation under general anesthesia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Control | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Klebanoff, MD | Christiana Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health System | Newark | Delaware | 19713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24288154 | Background | 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. | |
| 19896596 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure |
| FG001 | 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. Normal Saline: Equal volume injection of normal saline with the same paracervical technique |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure. Normal Saline: Equal volume injection of normal saline with the same paracervical technique |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | not avaialble | Posted | Mean | Standard Deviation | units on a scale | Immediate postoperatively through 8 hours post operation. |
|
From recovery through post operative Day 1
Postoperative Infection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Women undergoing endometrial ablation that meet the eligibility criteria will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure. Normal Saline: Equal volume injection of normal saline with the same paracervical technique |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Potsoperative Infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Hoffman Chair Department of OB/GYN | Christiana Care Health System | 302 733 3350 | mhoffman@christianacare.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2016 | Aug 13, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2016 | Aug 25, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Normal Saline | Other | Equal volume injection of normal saline with the same paracervical technique |
|
| 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 |
| 14511961 | Background | 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. |
| 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. Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Insurance | Count of Participants | Participants |
|
| Indication for Surgery | Count of Participants | Participants |
|
| Radiofrequency ablation | Count of Participants | Participants |
|
| Hydrothermoablation | Count of Participants | Participants |
|
| Thermachoice balloon | Count of Participants | Participants |
|
| Minerva Abltion | Count of Participants | Participants |
|
| Previous ceasrean delivery | Count of Participants | Participants |
|
| Previous tubal ligation | Count of Participants | Participants |
|
| Previous myomectomy | Count of Participants | Participants |
|
| Previous dilation and curettage | Count of Participants | Participants |
|
| OG001 | 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. Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure |
|
|
| Primary | Intraoperative Total Blood Loss | Amount of operative blood lost measured in milliliters | Data was only available for 37 patients in the Control group and 33 patients in the Treatment group | Posted | Median | Standard Deviation | cc | Intraoperative |
|
|
|
| Primary | 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. | Data was only available for 38 patients in the Control group and 38 patients in the Treatment group | Posted | Mean | Standard Deviation | Pills | Postoperative |
|
|
|
| Secondary | Occurrence of Intraoperative Complication | This represents any unanticipated complication related to the endometrial ablation. | Posted | Count of Participants | Participants | During Surgery |
|
|
|
| Secondary | Postoperative Complication | Any unanticipated complication related to the endometrial ablation. | Posted | Count of Participants | Participants | 1 Day Postoperative |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Predischarge from hospital |
|
|
|
| Secondary | Postoperative Toradol | Data was collected on whether or not the patient received Toradol following the endometrial ablation. Toradol is a non-narcotic pain medication. | Posted | Count of Participants | Participants | Postoperative |
|
|
|
| Secondary | Postoperative Anti-emetic | Data was collected on any nausea medicine administered following the endometrial ablation. | Posted | Count of Participants | Participants | Postoperative |
|
|
|
| Secondary | Time Between Recovery Initiation and Discharge | Time between arrival to the recovery room after surgery and discharge to home | Posted | Mean | Standard Deviation | hours | hours between recovery initiation and discharge |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 1 |
| 41 |
| EG001 | 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. Bupivacaine: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure | 0 | 41 | 0 | 41 | 2 | 41 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Failed Ablation |
|
| Incomplete Ablation |
|
| Fluid Overload |
|
| Hospital Readmission |
|
| Dialudid |
|
| Roxicodone |
|
| tylenol with Codeine |
|
| Reglan |
|
| Phenergan |
|