Port Size and Post-Operative Pain Perception by Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Participants will be asked to specify the point that represents their level of perceived pain intensity and mark it on the VAS at four time points.
研究概览
简要总结
The purpose of this study is to determine if there is a difference in pain perception by participants when the assistant port size varies by 50% (8 mm to 12 mm).
详细描述
Minimally invasive approaches trade a single longer incision for 4-5 smaller incisions that allow abdominal access and abdominal insufflation through "ports". The increase in operative times is mostly due to the need to pass suture, needles, cameras and instruments through the abdominal ports. While, it is intuitive that smaller abdominal ports will result in less pain at the incision site, the port size is also limited by instrument size and the size of the needle. When ports are smaller, it can take a little more time for a needle or instrument to be passed into the port.
There is a paucity of research comparing different port sizes as they relate to participate pain and operative time especially in a randomized controlled trial setting. The investigators goal would be to determine if there is a difference in pain perception by patients when the assistant port size varies by 50% (8 mm to 12 mm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •laparoscopic surgery for pelvic organ prolapse.
- •proficiency in English .
排除标准
- •Not proficiency in English
- •Previous participation/randomization in the study at a previous visit
- •Pregnant women cannot participate
- •History of abdominal wall pain
- •Chronic pain patients
研究组 & 干预措施
8mm Port
Participates will be randomized to have an 8 mm assistant port used during their surgery. The participate will be asked to specify the point that represents their level of perceived pain intensity and mark it on the scale at four time points: baseline pain prior to the procedure in the pre-operatively holding area, 4 to 6 hours post operatively, on Post Operative Day 1 (POD1). The final pain assessment will be at the two weeks postoperative clinic visit.
干预措施: 8mm port (Procedure)
12mm Port
Participates will be randomized to have an 12mm assistant port used during their surgery. The participate will be asked to specify the point that represents their level of perceived pain intensity and mark it on the scale at four time points: baseline pain prior to the procedure in the pre-operatively holding area, 4 to 6 hours post operatively, on Post Operative Day 1 (POD1). The final pain assessment will be at the two weeks postoperative clinic visit.
干预措施: 12mm port (Procedure)
结局指标
主要结局
Participants will be asked to specify the point that represents their level of perceived pain intensity and mark it on the VAS at four time points.
时间窗: 2 weeks post-op visit
Measured with Visual Analog Scale (VAS) for pain at 1) baseline pain prior to the procedure in the pre-operatively holding area, 2) 4-6 hours post-operatively in the post-anesthesia care unit (PACU), 3) on post-operative day 1(POD1) and 4) once two weeks post operatively.
次要结局
- What is the physician's perception of operative difficulty throughout the case? Determination of physician struggle and frustration will be documented.(Day of surgery)
研究者
Elizabeth Mueller
M.D., Associate Professor
Loyola University