Does Trendelenburg Positioning During Pulmonary Recruitment Breaths Affect Post-laparoscopy Shoulder Pain
2026年6月1日 更新者：Ankita Gupta
Trendelenburg Positioning During Pulmonary Recruitment Breaths: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether different positioning in the operating room during removal of laparoscopic surgical gas differs in post-surgery shoulder pain. An additional goal of this study is to evaluate whether positions change other post-surgery metrics such as bloating, time to passing gas, nausea and vomiting, and time to oral intake.
Researchers will compare Trendelenburg positioning where your head is tilted down to supine (level or flat) positioning during removal of surgical gas.
Participants will be asked to complete brief surveys at 24 and 72-hours post-surgery.
研究概览
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Debbie Shim
- 电话号码：502-561-7260
- 邮箱：deborah.shim@louisville.edu
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Robot-assisted laparoscopic surgery for benign gynecologic indication
- Surgery is booked for 60 minutes or longer
- Reliable working phone number or email
Exclusion Criteria:
- Patients with baseline opioid use
- Patients with existing shoulder or neck pain
- Active malignancy-related pain or surgery for malignant indication
- Concomitant upper abdominal or thoracic surgery
- Pre-existing emphysema, chronic obstructive pulmonary disease, or pneumothorax
- Non-English speaking
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：PRM Trendelenburg
PRM in Trendelenburg position (to 30 degrees or greatest degree patient can tolerate) with removal of tops of laparoscopic trocars
|
Active recruitment breaths delivered to patient by anesthesia provider as opposed to passive evacuation of pneumoperitoneum
其他名称：
Trendelenburg position as opposed to neutral (supine) position
|
|
有源比较器：PRM Supine
PRM in neutral position with removal of tops of laparoscopic trocars
|
Active recruitment breaths delivered to patient by anesthesia provider as opposed to passive evacuation of pneumoperitoneum
其他名称：
|
|
无干预：Passive Supine
control group with passive evacuation of pneumoperitoneum: insufflation evacuation by removal of tops of laparoscopic trocars in neutral (supine) position
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Post-laparoscopy shoulder pain, 24 hour VAS
大体时间：24 hours post-operatively
|
Post-laparoscopy shoulder pain assessed on a visual analog scale zero to ten with zero representing no pain and ten representing the worst pain of their life.
|
24 hours post-operatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Post-laparoscopy shoulder pain, 72 hour VAS
大体时间：72-hours post-operatively
|
Post-laparoscopy shoulder pain assessed on a visual analog scale zero to ten with zero representing no pain and ten representing the worst pain of their life.
|
72-hours post-operatively
|
|
Pain Interference, 24 hour
大体时间：24 hours post-operatively
|
Pain interference assessed by PROMIS Pain Interference Short Form 8a questionnaire.
A raw score ranges from 8 (least problems with pain hindering activities) to 40 (most problems with pain hindering activities).
|
24 hours post-operatively
|
|
Pain Interference, 72 hour
大体时间：72 hours post-operatively
|
Pain interference assessed by PROMIS Pain Interference Short Form 8a questionnaire.
A raw score ranges from 8 (least problems with pain hindering activities) to 40 (most problems with pain hindering activities).
|
72 hours post-operatively
|
|
Total opioid use, 24 hr
大体时间：24-hours postoperatively
|
total opioid use measured by MME
|
24-hours postoperatively
|
|
Total opioid use, 72 hr
大体时间：72-hours postoperatively
|
total opioid use at 72-hr postoperatively measured by total MME
|
72-hours postoperatively
|
|
Time to flatus
大体时间：up to 72-hours postoperatively
|
up to 72-hours postoperatively
|
|
|
Nausea and Vomiting, 24 hour
大体时间：24 hours post-operatively
|
Rhodes Index of Nausea Vomiting Retching is an 8-item questionnaire with scores ranging from 0 (no symptoms) to 32 (most severe symptoms).
|
24 hours post-operatively
|
|
Nausea and Vomiting, 72 hour
大体时间：72 hours post-operatively
|
Rhodes Index of Nausea Vomiting Retching is an 8-item questionnaire with scores ranging from 0 (no symptoms) to 32 (most severe symptoms).
|
72 hours post-operatively
|
|
Gas & Bloating, 24 hour
大体时间：24 hours post-operatively
|
Bloating measured by PROMIS Gas and Bloating 13a questionnaire.
The raw summed score ranges from 3 (no symptoms) to 36 (worst reported symptoms).
|
24 hours post-operatively
|
|
Gas & Bloating, 72 hour
大体时间：72 hours post-operatively
|
Bloating measured by PROMIS Gas and Bloating 13a questionnaire.
The raw summed score ranges from 3 (no symptoms) to 36 (worst reported symptoms).
|
72 hours post-operatively
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
- Berberoglu M, Dilek ON, Ercan F, Kati I, Ozmen M. The effect of CO2 insufflation rate on the postlaparoscopic shoulder pain. J Laparoendosc Adv Surg Tech A. 1998 Oct;8(5):273-7. doi: 10.1089/lap.1998.8.273.
- Ryu K, Choi W, Shim J, Song T. The impact of a pulmonary recruitment maneuver to reduce post-laparoscopic shoulder pain: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:55-60. doi: 10.1016/j.ejogrb.2016.11.014. Epub 2016 Nov 16.
- Kiyak H, Yilmaz G, Ay N. Semi-Fowler positioning in addition to the pulmonary recruitment manoeuvre reduces shoulder pain following gynaecologic laparoscopic surgery. Wideochir Inne Tech Maloinwazyjne. 2019 Dec;14(4):567-574. doi: 10.5114/wiitm.2019.84384. Epub 2019 Apr 11.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年10月1日
研究完成 (估计的)
2027年11月1日
研究注册日期
首次提交
2026年5月1日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年6月8日
上次提交的符合 QC 标准的更新
2026年6月1日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 25.0897
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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