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临床试验/NCT04459026
NCT04459026已完成4 期

Comparative Study Between Different Routes of Ropivacaïne Administration to Reduce Post-operative Pain in Gynecological Laparoscopy, a Double Blind Randomized Trial.

Universiteit Antwerpen2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
2
主要终点
need of pain medication postoperatively

研究概览

简要总结

The purpose of this study is to evaluate the effect of different routes of local anaesthesia administration in laparoscopic procedures to reduce post-operative pain (intra-peritoneal infusion of Ropivacaine 0.75%, port site injection of Ropivacaine 0.75% or a combination of both techniques), through a randomized one-center double-blinded study.

详细描述

Research Question What is the best route of Ropivacaine administration in laparoscopic procedures in decreasing post-operative pain? Is it port site injection, intra-peritoneal instillation of local anesthetics or is it a combination of both routes? Our hypothesis is that a combination of port site injection and intra-peritoneal instillation of local anesthetics will be more effective in lowering pain the first 24 hours after surgery.

  1. Characteristics of the patient population Inclusion criteria

  2. Elective gynecologic laparoscopy for benign conditions at Antwerp University Hospital.

  3. Successful laparoscopy without surgical or anesthetic complications.

  4. Female

  5. 18-70 years

  6. ASA( American Society of Anesthesia) I-II Exclusion criteria

(1) Hypersensitivity to anaesthetics of the amide-type (2) Obesity, BMI > 35 (3) Patients with chronic use of analgesics / chronic pain (4) Patients with an abnormal liver function (5) Urgent surgical procedures (6) Pregnancy (this means we only include patients who use contraceptives, are sterilized, have a negative dipstick testing or a negative serum testing or patients who are postmenopausal) 4. Characteristics of the treatment We will be using ropivacaine - naropin 7,5mg/ml, a local anaesthetic of the amide type. The administered dose of this local anaesthetic will be 3mg/kg for each patient. Depending on the study group the patient belongs to, this dose will be given in full by either local injection at the trocar entry points or by intraperitoneal injection or it will be divided between both injection sites, respectively 1mg at the trocar sites and 2mg intraperitoneal. The unequal dose distribution is based on the surface area the local anaesthetic has to cover.

  1. Methodology Anaesthetic management will be standardized for each person. The anaesthetist will insert an intravenous line and connect the patient to the monitor. We will be using routine intraoperative monitoring devices such as an electrocardiograph, a pulse oximetry and a non-invasive blood pressure monitor. The patient is preoxygenated with 100% O2 before induction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

The participant won't know to what study group they are assigned and will be under general anaesthesia. The study medication will be prepared in the operating room right before use. This means that neither the anaesthesiologist nor the surgeon, performing the surgery, are blinded. The investigators filling in the questionnaires, the patients or the nurses of the recovery room will always be blinded to the study groups, as will the nurse contacting the patients for the follow up.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective gynecologic laparoscopy for benign conditions at Antwerp University Hospital.
  • Successful laparoscopy without surgical or anesthetic complications.
  • 18-70 years

排除标准

  • Hypersensitivity to anaesthetics of the amide-type
  • Obesity, BMI > 35
  • Patients with chronic use of analgesics / chronic pain
  • Patients with an abnormal liver function
  • Urgent surgical procedures
  • Pregnancy (this means we only include patients who use contraceptives, are sterilized, have a negative dipstick testing or a negative serum testing or patients who are postmenopausal)

结局指标

主要结局

need of pain medication postoperatively

时间窗: one week

note in file

Abdominale Pain scores postoperatively

时间窗: one week

Numeric rating scale NRS

次要结局

  • problems with urinating postoperatively(one week)
  • shoulder pain postoperatively(one week)
  • postoperative nausea and vomiting(one week)
  • Activity level postoperatively: return to normal(one week)
  • itching postoperatively(one week)

研究者

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

Prof Yves Jacquemyn

Professor Jacquemyn

Universiteit Antwerpen

研究点 (2)

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