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临床试验/NCT04070924
NCT04070924撤回不适用

Surgical Dressings After Endoscopic Carpal Tunnel Release: A Randomized Controlled Trial

Chris Grandizio0 个研究点开始时间: 2024年3月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Visual Analog Scale Pain Score

研究概览

简要总结

Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. It is not currently known if dressing choices influence post-operative pain, function or patient satisfaction after ECTR. A less cumbersome dressing (bandaid) may allow patients to perform daily tasks with more ease after surgery. The purpose of this investigation is to compare postoperative pain scores and patient satisfaction after ECTR for patients treated with conventional post-operative bulky soft tissue dressings versus those treated with a bandaid after surgery. The hypothesis is that patients using a bandaid after surgery will have an easier time with functional tasks after surgery and that pain scores will not significantly differ between the two groups. Furthermore, this study aims to determine if there are differences in patient satisfaction, functional outcomes, complications, and unscheduled healthcare contact between these two groups. This will be a randomized, controlled investigation.

详细描述

Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. With recent attention to the opioid epidemic, there have been increasing efforts to reduce narcotic usage postoperatively while still controlling expected postoperative pain. Recent authors have found that many patients, particularly older patients, do not require any opioid analgesia after CTR with 47% of men and 36% of women consuming no narcotics after CTR (CHAPMAN). Furthermore, while splints have historically been used after surgery, their need has recently been questioned (LOGLI). It is not currently known if dressing choices influence post-operative pain, function or patient satisfaction after ECTR. A less cumbersome dressing (bandaid) may allow patients to perform daily tasks with more ease after surgery.

The purpose of this investigation is to compare postoperative pain scores and patient satisfaction after ECTR for patients treated with conventional post-operative bulky soft tissue dressings versus those treated with a bandaid after surgery. The hypothesis is that patients using a bandaid after surgery will have an easier time with functional tasks after surgery and that pain scores will not significantly differ between the two groups. Furthermore, this study aims to determine if there are differences in patient satisfaction, functional outcomes, complications, and unscheduled healthcare contact between these two groups. This will be a randomized, controlled investigation.

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
None

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

  • Patients 18 years of age or older
  • Patients undergoing primary, elective, unilateral ECTR under monitored anesthesia care with local anesthesia.

排除标准

  • Patients undergoing ECTR as part of a worker's compensation case
  • Patients currently incarcerated
  • Subject who cannot read and speak English

结局指标

主要结局

Visual Analog Scale Pain Score

时间窗: 0-12 months

best 0-10 worst; continuous scale to measure current pain level

次要结局

  • PROMIS Upper Extremity(0-12 months)
  • QuickDASH(0-12 months)
  • Satisfaction with overall outcome(0-12 months)
  • PROMIS Self-Efficacy Manage Symptoms(0-12 months)
  • morphine equivalents(0-12 months)
  • PROMIS Pain Interference(0-12 months)
  • number of participants with complications(0-12 months)
  • Boston Carpal Tunnel Questionnaire(0-12 months)
  • number of participants with unscheduled healthcare contact(0-12 months)
  • Satisfaction with the dressing(0-12 months)
  • Satisfaction postoperative pain control(0-12 months)
  • Grip Strength Measurement(0-12 months)

研究者

发起方
Chris Grandizio
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chris Grandizio

Attending Physician

Geisinger Clinic

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