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临床试验/NCT06491485
NCT06491485尚未招募4 期

Magnesium Sulfate Versus Sodium Bicarbonate as Adjuvants to Lidocaine 1% by Intraperitoneal Instillation for Postoperative Analgesics in Laparoscopic Gynecological Surgeries

Assiut University0 个研究点目标入组 90 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
90
主要终点
first rescue analgesia

研究概览

简要总结

The aim of this study is to compare intraperitoneal instillation of magnesium sulfate versus sodium bicarbonate as an adjuvant to lidocaine 1% , on reducing postoperative pain in laparoscopic gynecological surgeries.

详细描述

Patients undergoing laparoscopic surgery experience postoperative pain especially in the abdomen, lower back, and shoulders, Relieving postoperative pain, especially with certain types of analgesic agents, may reduce postoperative morbidity and mortality. It is also important to prevent adverse events such as myocardial infarction, cardiac arrhythmia, ileus, and poor wound healing and pulmonary complications. There is evidence that the main source of pain after laparoscopic surgeries is the peritoneum . Due to CO2 insufflation constitutes the commonest means of creating the pneumoperitoneum. Co2pneumoperitoneum is known to cause systemic acidosis. Which is responsible for damaging of the mesothelial lining of the peritoneum and consequent peritoneal irritation . Moreover, the phrenic nerve could be damaged by the acidic environment The use of local anesthetics has been advocated as a method for reducing postoperative pain local anesthetic intraperitoneal administration has shown good effects on reducing postoperative pain in laparoscopic cholecystectomy and gynecological surgeries . intraperitoneal sodium bicarbonate instillation may neutralize effect of the acid milieu on peritoneal cavity and the phrenic nerve damage which consecutively will lead to a reduction of postoperative pain. Magnesium sulfate, a non-competitive NMDA antagonist, has been proven in animal and human being models to have antinociceptive properties. The antinociceptive effect of magnesium sulfate relieves chronic pain and it can also decrease the duration and intensity of postoperative pain.

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
Female
接受健康志愿者

入选标准

  • age 18:60years
  • patients undergoing laparoscopic gynecological surgeries,

排除标准

  • patient dissatisfaction for participating in the study
  • opioid use within 24 hr before the study
  • allergy to the drugs used in the study and alcohol use
  • chronic pain syndrome.
  • neurological disease.
  • steroid treatment
  • conversion of laparoscopic surgery to open surgery
  • use a drain

研究组 & 干预措施

Group M (Magnesium sulfate)

Experimental

a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine with magnesium sulfate 50 mg/kg (maximum 2g) will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.

干预措施: Group M (lidocaine with Magnesium sulfate) (Drug)

Group B (Sodium bicarbonate)

Experimental

a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine with 50 ml 4.2% sodium bicarbonate will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.

干预措施: Group B (lidocaine with Sodium bicarbonate) (Drug)

Group C

Active Comparator

a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.

干预措施: Group C (lidocaine with saline) (Drug)

结局指标

主要结局

first rescue analgesia

时间窗: 24 hour postoperative

The first request for analgesia will be recorded by the nurse, and in case of pain in VAS more than 3, 1 gm of paracetamol will be administrated as a rescue analgesic if failed fentanyl 100mic will be added

次要结局

未报告次要终点

研究者

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

Mahmoud Hamza Abdelrady Abdelmalek

Resident doctor

Assiut University

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