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临床试验/NCT07583433
NCT07583433尚未招募不适用

Optimal Maneuver to Reduce Postoperative Pain Following Elective Laparoscopic Surgeries

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1

研究概览

简要总结

Laparoscopic surgery has revolutionized surgical care by reducing morbidity and improving post operative recovery. Laparoscopic surgery involves the use of carbon dioxide for insufflation to achieve optimal visualization. There is literature that demonstrates higher insufflation pressures being associated with increased postoperative pain - particularly shoulder pain - and opioid use. The ideal amount of intraperitoneal pressure is still under debate as other studies demonstrate that reduced pneumoperitoneum insufflation has also shown to negatively impact surgeon satisfaction and trended with longer operative time and greater blood loss without impacting pain.

Residual intraperitoneal carbon dioxide can also contribute to postoperative discomfort. Studies have shown the effectiveness of various maneuvers in removing residual gas to reduce postoperative pain, such as intraperitoneal saline instillation, pulmonary recruitment, and gas aspiration via smoke evacuator.

Despite these advantages, there is a lack of a clear consensus on the optimal method for reducing residual intraperitoneal gas. Conversely, literature has mixed results regarding the true significance in pain reduction.

Given the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, the investigators propose a prospective, patient-blinded, randomized controlled trial. The investigators aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain. The findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients age 18 to 65
  • Benign, elective laparoscopic surgeries

排除标准

  • Ages <18 and age >65
  • Emergency or urgent surgeries
  • Surgeries for chronic pelvic pain, malignancy
  • Surgeries during pregnancy
  • Severe cardiopulmonary disease
  • Prior extensive abdominal surgeries (more than 2 abdominal or pelvic surgeries)
  • Inability to consent

研究组 & 干预措施

Smoke Evacuation Group

Experimental

干预措施: Smoke Evacuation Group (Procedure)

Recruitment Breath Group

Experimental

干预措施: Recruitment Breath Group (Procedure)

Control Group

Placebo Comparator

干预措施: Control Group (Procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilinca Lupea

Principal Investigator

Henry Ford Health System

研究点 (1)

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