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临床试验/NCT03643666
NCT03643666Unknown3 期

Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic cholecystectomY

Cairo University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年10月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
75
试验地点
1
主要终点
Postoperative pain: VAS

研究概览

简要总结

Laparoscopic cholecystectomy has become a standard technique for gall bladder surgery. Benefits in comparison to conventional laparotomy are shorter lived effects on pulmonary function and less postoperative pain . However, patients often suffer from considerable pain during the first 24 postoperative hours. Pain can prolong hospital stay and lead to increased morbidity, which is particularly important now that many centers are performing this operation as a day-case procedure. Administration of intraperitoneal local anesthetic, either during or after surgery, is used by as a method of reducing postoperative pain. Although a number of studies have reported a significant reduction in postoperative pain after the use of intraperitoneal analgesia, others have reported no benefit. Several investigations have been conducted in order to find the cause of this pain. According to some of these investigations, the pain is attributed to peritoneal inflammation due to carbon dioxide pneumoperitoneum. Since steroids have been used for reducing inflammation, they may be considered as alternatives for relieving pain. Dexamethasone is a strong long acting glucocorticoid and it is widely used after surgery. it has been established that steroids are effective in relieving postoperative pain in laparoscopic cholecystectomy. Also, administration of magnesium sulphate has been shown to have a potential to prevent postoperative pain and to reduce intra operative anesthetic and analgesic requirements being an antagonist of N-methyl-D-aspartate (NMDA) receptors and its associated ion channels. Some studies showed reduction of pain scores if magnesium sulphate was injected intra-articular and intraperitoneal with no serious adverse effects. In this study the investigators will use intraperitoneal dexamethasone vs dexamethasone plus magnesium sulphate to study their analgesic efficacy after laparoscopic cholecystectomy as the investigators assume that the combination of both drugs will provide stronger analgesia than dexamethasone alone

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age group and gender: between 18 to 60 years both males and females
  • American Society of Anesthesiologists (ASA) physical status I-II

排除标准

  • Age < 18 years or > 60 years
  • ASA physical status III or IV
  • Patients with diabetes
  • Patient refusal to participate in the study
  • Chronic respiratory disease
  • Advanced renal or hepatic diseases
  • Use of opioids, tranquilizers or steroids
  • Confusion or psychiatric illness
  • Acute cholecystectomy
  • Patients with peritoneal drain after surgery

研究组 & 干预措施

control group

Placebo Comparator

this group will include 25 patients receiving intraperitoneal 40 ml of normal saline only at the end of laparoscopic cholecystectomy

干预措施: Placebo (saline) (Drug)

dexamethasone group

Active Comparator

this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone in 40 ml saline at the end of laparoscopic cholecystectomy

干预措施: dexamethasone (Drug)

dexamethasone plus magnesium sulphate group

Active Comparator

this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone plus 2 gm magnesium sulphate at the end of laparoscopic cholecystectomy

干预措施: dexamethasone (Drug)

dexamethasone plus magnesium sulphate group

Active Comparator

this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone plus 2 gm magnesium sulphate at the end of laparoscopic cholecystectomy

干预措施: magnesium sulphate (Drug)

结局指标

主要结局

Postoperative pain: VAS

时间窗: first 24 hours

Postoperative pain scoring using standard Visual Analogue Scale (VAS) pain score of 0-10 (with 0 meaning no pain and 10 meaning the most intense pain ever experienced)

次要结局

  • Heart rate(first 24 hours)
  • arterial blood pressure measurement postoperative(first 24 hours)
  • Postoperative nausea and vomiting(first 24 hours)
  • doses of consumed postoperative analgesics(first 24 hours)

研究者

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

AbdElKhalik Mahmoud Shaban

Principal Investigator

Cairo University

研究点 (1)

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