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OpenTrials
Completed

NCT Number: NCT02660918

Decreasing Postoperative Pain Following Endometrial Ablation

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

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Key information

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health System

Newark, Delaware, 19713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine

Drug

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

Other names: Marcaine, Sensorcaine

Normal Saline

Other

Equal volume injection of normal saline with the same paracervical technique

Primary outcomes

  1. Postoperative Pain Score

    Time frame: Immediate postoperatively through 8 hours post operation.

    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

  2. Intraoperative Total Blood Loss

    Time frame: Intraoperative

    Amount of operative blood lost measured in milliliters

  3. Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge

    Time frame: Postoperative

    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 outcomes

  1. Occurrence of Intraoperative Complication

    Time frame: During Surgery

    This represents any unanticipated complication related to the endometrial ablation.

  2. Postoperative Complication

    Time frame: 1 Day Postoperative

    Any unanticipated complication related to the endometrial ablation.

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

    Time frame: Predischarge from hospital

    Narcotic medications administered in the recovery area before the patient was discharged from the Surgicenter.

  4. Postoperative Toradol

    Time frame: Postoperative

    Data was collected on whether or not the patient received Toradol following the endometrial ablation. Toradol is a non-narcotic pain medication.

  5. Postoperative Anti-emetic

    Time frame: Postoperative

    Data was collected on any nausea medicine administered following the endometrial ablation.

  6. Time Between Recovery Initiation and Discharge

    Time frame: hours between recovery initiation and discharge

    Time between arrival to the recovery room after surgery and discharge to home

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 21, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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