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临床试验/NCT04651556
NCT04651556已完成4 期

Comparison Of Intraperitoneal Instillation Of Magnesium Sulphate and Bupivacaine Versus Intravenous Analgesia In Laparoscopic Surgeries In Pediatrics

Menoufia University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年4月4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
已完成
入组人数
66
试验地点
1
主要终点
FLACC score

研究概览

简要总结

The investigators are going to study the analgesic efficacy of intraperitoneal instillation of a combination of Magnesium sulphate with bupivacaine versus ordinary used parenteral analgesics for pain relief after laparoscopic surgeries in pediatrics.

详细描述

Laparoscopic surgery is a modern surgical technique used for various surgeries such as cholecystectomy, appendectomy and hernia repair. There are a number of advantages of this technique including reduced pain and bleeding, shorter recovery time and hospital stay, and over all reduced healthcare costs. The type of pain after laparoscopic surgery differs considerably from that occurs after laparotomy. Usually patients experience diffuse pain in abdomen, back and shoulder. Acute pain after laparoscopic cholecystectomy has three different components: incisional pain (somatic pain), visceral pain (deep intra-abdominal pain), and shoulder pain (presumably referred visceral pain) . Postoperative nausea and vomiting is a commonly observed phenomenon after laparoscopic procedures. Its incidence increases depending on the anesthetic techniques used. Pain intensity usually peaks during the first postoperative period and usually declines over the following 2-3 days. Pain can prolong hospital stay and lead to increased morbidity.

Inadequately treated pain may lead to splinting, loss of sighing and decrease in vital capacity, and these may contribute to postoperative pulmonary morbidity. Various multimodal approaches have, therefore, been tried to ameliorate postoperative pain. These include parenteral analgesics, local infiltration with local anesthetics, epidural and intrathecal opioids and local anesthetics, interpleural and intercostals nerve blocks as well as intraperitoneal routes that in turn has been explored with local anesthetics and opioids . In order to get an instant relief, polypharmacy is commonly practiced which can be potentially harmful to the patient and can lead to re-admission. It has been appreciated that multiple glutamate receptors are expressed on peripheral nerve terminals, and these may contribute to peripheral nociceptive sensation .

Administration of magnesium sulphate via different routes has been used in anaesthetic practice for decreasing perioperative pain. Parenteral magnesium sulphate has been used for many years as an antiarrhythmic agent and for seizure prophylaxis in eclampsia and preeclampsia. It is N-methyl d-aspartate (NMDA) receptor antagonist and suppresses these receptor induced inflammation and hyper responsiveness . The antinociceptive effect of magnesium sulphate is not only useful in chronic pain, but it also determines in part, the duration and intensity of postoperative pain . These effects are due to calcium antagonism and decrease influx of calcium into the cell and antagonism of NMDA receptor. As these receptors regulate neuronal signalling and are involved in pain processing, magnesium sulphate by blocking this receptor, decreases postoperative pain as well .

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 (Participant, Care Provider)

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I-II.
  • Both genders are eligible for study.
  • Patients age from 1 year to 12 years.
  • Patients undergoing laparoscopic surgeries.

排除标准

  • 1- ASA III, IV and V class patients. 2- Presence of psychiatric disease. 3- Those with an allergy to any of the study drugs will be excluded from the study.

研究组 & 干预措施

Parenteral Analgesia

Active Comparator

receive ordinary analgesics via intravenous route as paracetamol (7.5- 10 mg/kg) and ketorolac (0.5 mg/kg).

干预措施: paracetamol & ketorolac (Drug)

Intraperitoneal instillation

Active Comparator

receive (Magnesium sulphate 40 mg/kg and bupivacaine 4mg/kg) in 30 ml of isotonic 0.9%N.S intra peritoneal at the end of surgery.

干预措施: Magnesium Sulfate & bupivacaine (Drug)

结局指标

主要结局

FLACC score

时间窗: 24 hours postoperative

(Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.

次要结局

  • Vital signs(preoperative, postoperative (0,1,3,6,12,24 hours))
  • Time to first analgesic administration(24 hours postoperative)
  • Total analgesic requirements(24 hours postoperative)

研究者

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

Ibrahim Walash

assistant lecturer

Menoufia University

研究点 (1)

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