Decreasing Postoperative Pain Following Endometrial Ablation

Postoperative Pain Clinical Trial

Official title:

Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660918
• Other study ID #: 35179
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2019
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Other:
• Normal Saline
Equal volume injection of normal saline with the same paracervical technique

Locations

Country	Name	City	State
United States	Christiana Care Health System	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Immediate postoperatively through 8 hours post operation.
Primary	Intraoperative Total Blood Loss	Amount of operative blood lost measured in milliliters	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.	Postoperative
Secondary	Occurrence of Intraoperative Complication	This represents any unanticipated complication related to the endometrial ablation.	During Surgery
Secondary	Postoperative Complication	Any unanticipated complication related to the endometrial ablation.	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.	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.	Postoperative
Secondary	Postoperative Anti-emetic	Data was collected on any nausea medicine administered following the endometrial ablation.	Postoperative
Secondary	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