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临床试验/NCT00950625
NCT00950625已完成不适用

Comparison of Analgesic Efficacy of Intra-peritoneal Lignocaine With Bupivacaine After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial

Aga Khan University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年8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
入组人数
200
试验地点
1
主要终点
Pain Control after Laparoscopic Cholecystectomy

研究概览

简要总结

Although laparoscopic cholecystectomy is associated with less pain than contemporary open procedures; it is definitely not pain free and the magnitude of postoperative shoulder and abdominal pain in the early postoperative period is still quite significant. This postoperative pain is a major concern not only for the patients, but also healthcare workers; and it often contributes to overnight hospital stay after this minimally invasive surgical procedure. Intraperitoneal instillation of local anesthetics at the time of surgery to control pain after laparoscopic cholecystectomy has been extensively studied in numerous randomized trials and found to be extremely useful. Lignocaine and Bupivacaine are two commonly used local anesthetic agents. In view of contradictory results from previous studies, it is not yet clear which of these two agents is superior to the other for pain control in this setting. To answer this question, we have designed a prospective randomized controlled trial and the specific aim of the study is to compare the analgesic efficacy of intraperitoneal lignocaine with intraperitoneal Bupivacaine in the postoperative setting after laparoscopic cholecystectomy.

If we can improve pain control after this minimally invasive procedure, it might result in decreased postoperative requirement of narcotic analgesia and its associated side-effects. It may also result in early recovery and the same day discharge of the patients with significant cost-containment for the patient and healthcare systems in future.

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 (Care Provider, Investigator)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy
  • Elective surgical procedure
  • American Society of Anesthesiologists class I and II

排除标准

  • Patients refusing randomization
  • Patients already on analgesics
  • Patients with acute cholecystitis
  • Patients requiring preoperative cholangiogram or common bile duct exploration
  • Patients having bile or stone spillage during procedure
  • Patients requiring conversion to open procedure
  • Patients requiring re-exploration for any reason
  • Patients with history of allergy to local anesthetic agents

研究组 & 干预措施

intraperitoneal lignocaine

Active Comparator

Intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine for pain control after laparoscopic cholecystectomy

干预措施: lignocaine (Drug)

intraperitoneal lignocaine

Active Comparator

Intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine for pain control after laparoscopic cholecystectomy

干预措施: bupevacaine (Drug)

intraperitoneal bupevacaine

Active Comparator

intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy

干预措施: lignocaine (Drug)

intraperitoneal bupevacaine

Active Comparator

intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy

干预措施: bupevacaine (Drug)

结局指标

主要结局

Pain Control after Laparoscopic Cholecystectomy

时间窗: 24 hours after surgery

次要结局

  • Requirement of Analgesia after laparoscopic cholecystectomy(24 hours after surgery)

研究者

申办方类型
Other

研究点 (1)

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