Decreasing Postoperative Pain Following Endometrial Ablation

NCT02660918 | Completed Results

• 1 other identifier: 35179
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Occurrence of Intraoperative Complication

  During Surgery

• Postoperative Complication

  1 Day Postoperative

• Postoperative Opioid Administered Following the Procedure But Prior to Discharge.

  Predischarge from hospital

• Postoperative Toradol

  Postoperative

• Postoperative Anti-emetic

  Postoperative

Study Arms (2)

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.

Drug: Bupivacaine

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.

Other: Normal Saline

Interventions

Bupivacaine DRUG

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

Also known as: Marcaine, Sensorcaine

Treatment

Normal Saline OTHER

Equal volume injection of normal saline with the same paracervical technique

Control

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

Related 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.

  PMID: 24288154 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.

  PMID: 19896596 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.

  PMID: 14511961 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Matthew Hoffman Chair Department of OB/GYN
• Organization: Christiana Care Health System

mhoffman@christianacare.org

302 733 3350

Study Officials

• Jordan Klebanoff, MD

  Christiana Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 21, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)