Randomized Prospective Interventional Study: Pain Relief After Laparoscopic Primary Hiatal Hernia Repair
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Opioid and Non-Opioid Usage Postoperative Period
研究概览
简要总结
Referred shoulder pain (pain felt when the problem is actually in a different location) is very common after laparoscopic (small, narrow cut) hernia surgery. The purpose of this study is to look at the effect of a simple back massager, which can be readily purchased online or in a store, in addition to the use of standard pain medications.
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
- 否
入选标准
- •Scheduled for primary hiatal hernia repair
- •Adult 18 years of age or older
- •Undergoing minimally invasive surgical technique
排除标准
- •Recurrent hiatal hernia
- •Children under the age of 18 years
- •Undergoing open or hybrid surgical technique
- •History of psychiatric disorder or chronic pain
- •Has a post-operative complication (Grade > I on Calvien Dindo classification)
- •Allergy to standard pain medication regimen (local anesthetics Marcaine, lidocaine, and epinephrine; morphine; oxycodone; Tylenol)
研究组 & 干预措施
Back Massager Device + Standard Pain Treatment
Resteck Shiatsu Neck and Back Massager (brand name), with recommended use for at least every 2 hours for at least 15 minutes on the first post-operative day and then every 4 hours for 2 days and then as needed.
Standard pain treatment:
- Local anesthetic agent at the incision sites include: 0.5% Marcaine (10 cc) + 0.5% lidocaine and epinephrine (10 cc) (total volume: 20 cc)
- Morphine 2 mg: Intravenous administration every 2 hours or as needed, if unable to take pills by mouth
- Oxycodone 5 - 10 mg elixir: oral administration every 6 hours or as needed
- Tylenol 650 mg Tab: oral administration every 6 hours
干预措施: Resteck Shiatsu Neck and Back Massager (Device)
Marcaine spray + Standard Pain Treatment
30cc of 0.25% Marcaine spray on the diaphragm at the end of surgery.
Standard pain treatment:
- Local anesthetic agent at the incision sites include: 0.5% Marcaine (10 cc) + 0.5% lidocaine and epinephrine (10 cc) (total volume: 20 cc)
- Morphine 2 mg: Intravenous administration every 2 hours or as needed, if unable to take pills by mouth
- Oxycodone 5 - 10 mg elixir: oral administration every 6 hours or as needed
- Tylenol 650 mg Tab: oral administration every 6 hours
干预措施: Marcaine (Drug)
结局指标
主要结局
Opioid and Non-Opioid Usage Postoperative Period
时间窗: 2 years
Subject diary to list any medications taken for pain relief after surgery, and will list the following: name of medication, dose of medication, date and time medication taken
Visual Analogue Score Pain Questionnaire
时间窗: 2 years
Pain score questionnaire to rate pain on a scale of 0 - 10, with 0 being no pain and 10 being the worst possible pain imaginable. The higher the score, the worse the outcome.
次要结局
未报告次要终点
研究者
Leslie Munson
Research Program Manager
Norton Thoracic Institute