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临床试验/NCT02004470
NCT02004470Unknown不适用

Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain: A Randomized Controlled Trial

University of Tennessee4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
4
主要终点
Pain Score

研究概览

简要总结

The use of laparoscopy in gynecologic surgery has been well established to decrease morbidity, blood loss, hospital stay, and post-operative pain when compared to traditional open abdominal surgery. However, the laparoscopic technique is associated with post-operative shoulder pain.

We hypothesize that a combination of intraperitoneal saline lavage and active suction removal of carbon dioxide gas from the right upper quadrant of the abdomen will decrease incidence of post-laparoscopic shoulder pain when compared to passive exsufflation of carbon dioxide gas.

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 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •English speaking patient
  • •Age 18-75
  • •must undergo laparoscopic surgery
  • •willing to participate in the study

排除标准

  • •Male patients
  • •Under 18 or older than 75
  • •Laparoscopic procedures that get converted to laparotomy
  • •Intraoperative hemorrhage more than 500 cc
  • •Patients with active joint disease
  • •History of shoulder surgery
  • •Intraoperative laceration to the liver
  • •Malignancy
  • •Long term daily narcotic use
  • •Chronic right upper quadrant/ shoulder pain
  • •Pregnancy
  • •History of dementia, Alzheimers, stroke or other condition causing altered mental status

研究组 & 干预措施

Passive exsufflation

No Intervention

Will not actively suction carbon dioxide from abdomen. Open laparoscopic trocars and allow C02 to passively empty from abdomen.

Active lavage and suction

Experimental

This step is already employed in many ongoing surgeries where normal saline will be used to lavage the right upper quadrant and then will be suctioned out to remove as much Carbon dioxide from the patient's abdomen and to therefore decrease postoperative pain.

干预措施: Active lavage and suction (Procedure)

结局指标

主要结局

Pain Score

时间窗: 48 hours

We will assess a pain score based on a visual analog score of 1-10 at 48 hours post operatively.

Pain Score

时间窗: 12 hours

We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.

Pain Score

时间窗: 24 hours

We will assess a pain score at 24 hours post operatively based on a visual analog score of 1-10

次要结局

  • operative time(24 hours)
  • blood loss(6 hours)
  • analgesic use(7 days)
  • Anti emetic use(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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