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临床试验/NCT03867552
NCT03867552已完成不适用

Pain Relief in Laparoscopic Surgery - to Relief Pain After Laparoscopic Surgery With the Use of a Altered Gas

Jessa Hospital2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
2
主要终点
Assessment of post-operative pain with an 11-point numerical rating score (NRS)

研究概览

简要总结

Pain relief after laparoscopic surgery with the use of an altered gas.

详细描述

Pain after laparoscopic surgery remains an important concern in the treatment of endometriosis or other gynaecologic laparoscopic surgery. Several trials have demonstrated that the use of an altered insufflation gas (10 % nitrous oxide + 4% oxygen + 86% carbon dioxide) reduces pain. It also decreases inflammation and adhesion formation as a surplus.

With this mono-center, investigator initiated, double-blinded, randomized controlled superiority trial, the investigators want to demonstrate a reduced postoperative pain and peritoneal inflammatory reaction following peritoneal conditioning with an altered insufflation gas compared to the standard carbon dioxide (100% CO2) insufflation gas. Therefore, women undergoing laparoscopic (gynaecological) surgery with an estimated surgical time of >60 minutes will be asked to participate in this trial. Baseline characteristics will be assessed, including the patients' age, body mass index, medial history, American Society of Anesthesiologist Classification (ASA classification), work status, highest level of education, fear for the surgical procedure (using an 8-item surgical fear questionnaire), pre-operative pain (using a Numerical Rating Scale (NRS) were 0= no pain and 10= worst pain imaginable) both in resting position and in an active position), expected pain (NRS), baseline quality of recovery (QOR) (using the 1-item Global Surgical Recovery (GSR) index (3) and the Functional Recovery Index (FRI) (4)) as well as baseline quality of Life (QOL), using the 5-dimensional European Quality of Life (EQ-5D) questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Woman ≥ 18 years old
  • undergoing laparoscopic surgery for endometriosis, uterine myoma's, hysterectomy or colpopexy.

排除标准

  • Women < 18 years old
  • Pregnancy
  • Conditions associated with chronic pain, such as peripheral neuropathy, pathology of the vertebral column and osteo-articular disease.
  • Conditions causing acute pain e.g. abdominal trauma

结局指标

主要结局

Assessment of post-operative pain with an 11-point numerical rating score (NRS)

时间窗: 4 hours after laparoscopic surgery

Assessement of pain after laparoscopic surgery with the use of the altered gas compared to standard gas with NRS, where 0 means no pain and 10 means worst imaginable pain

次要结局

  • Assessment of post-operative pain (NRS)(8 hours, 24 hours and 7 days after laparoscopic surgery)
  • Nausea(4 hours, 8 hours, 24 hours and 7 days after laparoscopic surgery)
  • Post-operative use of piritramide (Dipidolor®)(Up to 24 hours after laparoscopic surgery)
  • Time to resumption of transit(Through study completion, up to 7 days after laparoscopic surgery)
  • Patient satisfaction(7 days after laparoscopic surgery)
  • Assessment of degree of a possible inflammatory reaction(Through study completion, up to 7 days after laparoscopic surgery)
  • Assessment of quality of Recovery (QOR)(24 hours and 7 days after laparoscopic surgery)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stessel Björn

Principal Investigator, Anesthesiologist, MD, PhD

Jessa Hospital

研究点 (2)

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