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临床试验/NCT01388946
NCT01388946已完成不适用

Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy. A Randomized Controlled Double-blind Trial

University of Athens2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
2
主要终点
VAS Score Changes ( Cough) During 24 h Postoperatively

研究概览

简要总结

The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the analgesic consumption during the first 24 hours.

详细描述

Patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive via a subcutaneous catheter 2 ml per hour of 0.75 ropivacaine or same volume of normal saline. The catheter was inserted after induction of general anesthesia and before beginning of surgery and continued for the first 24 postoperative hours. The solutions were administered by means of an elastomeric pump. Before induction of anesthesia metoclopramide 10 mg, ranitidine 50 mg and droperidol 0.75 mg were given intravenously. In the operating room the routine monitoring was applied. Anesthesia was induced with thiopental 5-6 mg/kg, fentanyl 2 μg/kg, and rocuronium 0.6 mg/kg, and maintained with sevoflurane 1-1.5 Minimum Alveolar Concentration (MAC) in a nitrous oxide/oxygen mixture. After induction of anesthesia diclofenac 75 mg I.V was given within 30 min. Before wound closure each hole was infiltrated with 2 ml of ropivacaine 0.75 or normal saline. At the end of surgery neuromuscular block was reversed with sugammadex 2 mg/kg., the patient was extubated and transferred to the Post-anesthesia Care Unit (PACU).

Intra-operatively, the intra-abdominal pressure, the rate of carbon dioxide insufflation and the total amount of carbon dioxide insufflated are recorded every 5 minutes.

Besides the ropivacaine infusion in the operative site, postoperative analgesia is assured in the PACU with paracetamol 1 gr and tramadol 100 mg if Visual Analogue Scale (VAS) score is above 40 mm.In the ward Lonarid tablets are given instead.

VAS values and analgesic consumption are recorded in the PACU, and 2, 4, 8, 24 and 48 hours after surgery.

The catheter is removed 24 hours after surgery. One and three months after surgery patients are interviewed by phone for the presence of pain due to surgery.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status I-III
  • Scheduled for laparoscopic cholecystectomy

排除标准

  • Patients with chronic pain and/or on analgesics for the last month,
  • Patients with central nervous, kidney and liver disease, or allergy to local anesthetics

研究组 & 干预措施

Ropivacaine 0.75

Active Comparator

Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours

干预措施: Ropivacaine 0.75 (Drug)

Normal saline

Placebo Comparator

Continuous infusion of normal saline 2 ml/h for 24 hours

干预措施: Normal saline (Drug)

结局指标

主要结局

VAS Score Changes ( Cough) During 24 h Postoperatively

时间窗: 24 h

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

次要结局

  • Pain Scores in the Postoperative Care Unit (PACU) at Rest(in PACU)
  • Pain Scores at Rest 2 h Postoperatively(2 h postoperatively)
  • Pain Scores at Rest 4 h Postoperatively(4 h)
  • Pain Scores at Rest 8 h Postoperatively(8 h)
  • Pain Scores at Rest 24 h Postoperatively(24h)
  • Pain Scores at Rest 48 h Postoperatively(48 h)
  • Pain Scores During Cough in the PACU(PACU)
  • Pain Scores During Cough 2 h Postoperatively(2 h)
  • Chronic Pain(three months)
  • Pain Scores During Cough 8 h Postoperatively(8 h)
  • Pain Scores During Cough 48 h Postoperatively(48 h)
  • Pain Scores During Cough 4 h Postoperatively(4 h)

研究者

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

Argyro Fassoulaki

MD, PhD, DEAA

University of Athens

研究点 (2)

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