Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair: a Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduction in post-operative shoulder pain
研究概览
简要总结
The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia repair in hopes of reducing pain and associated costs as well as clinic and emergency department visits due to this pain. You will undergo standard robot-assisted hiatal hernia repair with the standard postoperative care. The only difference is that you may be selected for the group where lower pressures used to fill your abdomen with carbon dioxide will be used, and you will be asked to fill out logs regarding your pain postoperatively. You will have postoperative appointments that are standard following this procedure.
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
- 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
- •patients undergoing elective robot assisted hiatal hernia repair
排除标准
- •patients less than 18 years of age
- •conversion to open surgery
- •BMI > 40
- •history of abdominoplasty
- •history of chronic pain and/or opioid dependence
- •history of COPD and/or supplemental oxygen use
- •pregnant patients
- •incarcerated patients
- •patient refusal
研究组 & 干预措施
Low Pressure Pneumoperitoneum (8-10 mmHg)
Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 8-10 mmHg throughout the case
干预措施: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device (Procedure)
Standard Pressure Pneumoperitoneum (13-15 mmHg)
Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 13-15 mmHg throughout the case
干预措施: Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device (Procedure)
结局指标
主要结局
Reduction in post-operative shoulder pain
时间窗: 1 week (on average)
Percentage reduction in post-operative shoulder pain from POD#0 to \~1 week post-operative telephone appointment
次要结局
- Severity of postoperative shoulder pain on POD #0(6 hours (on average))
- Severity of postoperative shoulder pain on POD #1(18 hours (on average))
- Severity of postoperative shoulder pain at ~1 week(1 week (on average))
- Severity of postoperative shoulder pain at ~2 weeks post-op(2 weeks (on average))
- length of hospital stay(through study completion, an average of 2 years)
- readmission rates for shoulder pain(through study completion, an average of 2 years)
- number of postoperative clinic visits related to shoulder pain management(through study completion, an average of 2 years)
- discharge disposition(through study completion, an average of 2 years)
- standard vs extended narcotic regimen(through study completion, an average of 2 years)
- quality of life(1 week (on average))