跳至主要内容
临床试验/NCT03702647
NCT03702647已完成不适用

Ropivacaine For Post-POEM Pain Control

Lawrence Charles Hookey1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月1日最近更新:
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
发起方
入组人数
20
试验地点
1
主要终点
Post-POEM pain level

研究概览

简要总结

POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax.The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms.This study seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications.

详细描述

POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax. Consequently, patients experience difficulty swallowing, reflux, and weight loss. Treatment options for achalasia are generally divided into 2 categories: A) treatment with medication, or B) treatment via a procedure. Medical treatment is generally reserved for patients to unwell to undergo procedures as the efficacy is low. Additionally, patients tend to experience many side-effects. There are also procedural options used to treat achalasia which include surgical myotomy and POEM. The POEM procedure is advantageous because it is less invasive, but is at least as equally effective for symptomatic relief when compared to the surgical myotomy. The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms. At the conclusion of the procedure, clips are placed in the esophagus to close the incision. Currently, patients are given intravenous ketorolac, oral viscous lidocaine and narcotic analgesics as needed to manage post-operative pain. This study, however, seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications. Patients consented to participate in the study will be randomized to receive either ropivacaine (intervention group) or saline (control group). Pain will be assessed at 0.5, 1, 2, 4, and 6 hours post-admission to the recovery unit using validated pain scales. Additionally, the Quality of Recovery (QoR-15) patient survey, will be completed prior to discharge. This measure will capture the patient's initial post-operative health condition and help capture the overall patient experience.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Patients will be randomized by an independent research pharmacist to receive either 30mL 0.2% ropivacaine or 30mL of placebo (saline), both being clear, colorless solutions. These samples will be prepared by the research pharmacist 2-3 weeks prior to the procedure and stored until the procedure date as per pharmacy standards. On the morning of the procedure, the study solution will be taken to the operating room with the patient. During the POEM procedure, prior to closure of the mucosotomy, the study solution is instilled into the tunnel. The investigator, patient, care provider, and research coordinator will be blinded to the group assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age and older undergoing POEM procedure
  • Able to provide written informed consent
  • Fluent and literate in English

排除标准

  • Patients with known adverse reactions to local anesthetics and NSAIDs (GFR<50)
  • Patients with chronic pain taking regular analgesics or narcotics (requiring daily opioid therapy > 30 mg morphine or equivalents)
  • Patients unable to give informed consent

研究组 & 干预措施

Ropivacaine

Experimental

30mL of 0.2% Ropivacaine placed in the POEM tunnel

干预措施: Ropivacaine (Drug)

Normal Saline

Placebo Comparator

30mL of normal saline placed in the POEM tunnel

干预措施: Normal saline (Drug)

结局指标

主要结局

Post-POEM pain level

时间窗: 6 hours post-POEM procedure

To assess the effect of the intervention/placebo on pain 6-hours post-POEM as assessed via the Numeric Rating Scale (NRS): The patient will be asked to rate their pain on a scale of 0-10, 0 representing no pain, and 10 representing the worst pain they have ever felt in their life.

次要结局

  • Repeatability of procedure(Assessed 24 hours post-POEM procedure)
  • Adverse Events(Assessed up to 24 hours post-POEM procedure)
  • Fentanyl consumption(Intra-procedure)
  • Post-POEM pain level(0, 0.5, 1, 2, 4 hours post-POEM procedure)
  • Quality of Recovery (QoR-15) score on the day of discharge(Assessed up to 24 hours post-POEM procedure)
  • Post-POEM analgesic(0 -6 hours post-procedure)

研究者

发起方
Lawrence Charles Hookey
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lawrence Charles Hookey

Associate Professor

Queen's University

研究点 (1)

Loading locations...

相似试验