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临床试验/NCT03612947
NCT03612947已完成2 期

Effect of Magnesium Sulfate When Added to TAP Block With Bupivacaine in Patients Undergoing Laparoscopic Cholecystectomy.

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
The postoperative pain

研究概览

简要总结

Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery. Recently, magnesium sulphate is used as adjuvant to local anesthetics.

详细描述

A significant pain experienced by patients after laparoscopic cholecystectomy surgery is required so as to block nociceptive transmission from both the abdominal wall incision, and visceral sites.

Using of opioids can result in significant adverse effects, thus delaying early mobilization of patients.

Ultrasound-guided transversus abdominis plane (TAP) block has been used as a satisfactory approach that provides postoperative analgesia. TAP block is safe; it diminishes or replaces the use of opioids; and it has a lower incidence of adverse effects.

Bupivacaine is a medication used to decrease feeling in a specific area. It is used by injecting it into the area, around a nerve that supplies the area, or into the spinal canal's epidural space. Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks.

Magnesium is the fourth most plentiful cation in our body. It may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (age: 18-65 years old) undergoing laparoscopic cholecystectomy.

排除标准

  • Patient refusal
  • Patients with a history of cardiac, or respiratory diseases ( >ASA III).
  • Patients with allergy to amide local anesthetics or medication included in the study.
  • Infection at the needle insertion site.
  • Pregnancy
  • Drug abusers

研究组 & 干预措施

Bupivacaine +magnesium sulphate

Active Comparator

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4.

干预措施: Bupivacaine +magnesium sulphate (Drug)

Bupivacaine only

Placebo Comparator

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).

干预措施: Bupivacaine only (Drug)

结局指标

主要结局

The postoperative pain

时间窗: The first 24 hours after surgery

Visual analogue pain score ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain.

次要结局

  • Time to first dose of post-operative analgesia(First occurrence during hospitalization (up to 24 hours postoperatively))
  • Postoperative nausea and vomiting(The first 24 hours after surgery)
  • postoperative sedation(The first 24 hours after surgery)
  • Patient satisfaction(At 24 hours after surgery)

研究者

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

Seham Mohamed Moeen Ibrahim

Principal Investigator

Assiut University

研究点 (1)

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TAP Block in Laparoscopic Cholecystectomy. | 临床试验