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临床试验/NCT02660918
NCT02660918已完成不适用

Decreasing Postoperative Pain Following Endometrial Ablation: A Randomized Controlled Trial

Christiana Care Health Services1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Normal Saline (Other)

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.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

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

时间窗: 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.

Postoperative Pain Score

时间窗: 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

Intraoperative Total Blood Loss

时间窗: Intraoperative

Amount of operative blood lost measured in milliliters

次要结局

  • Postoperative Complication(1 Day Postoperative)
  • Time Between Recovery Initiation and Discharge(hours between recovery initiation and discharge)
  • Occurrence of Intraoperative Complication(During Surgery)
  • Postoperative Anti-emetic(Postoperative)
  • Postoperative Opioid Administered Following the Procedure But Prior to Discharge.(Predischarge from hospital)
  • Postoperative Toradol(Postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordan Klebanoff

Principal Investigator

Christiana Care Health Services

研究点 (1)

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