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临床试验/NCT05158647
NCT05158647已完成2 期

Efficacy of Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block in Acute Postherniorrhaphy Pain

Abdelrady S Ibrahim, MD1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年8月12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
发起方
入组人数
90
试验地点
1
主要终点
Postoperative incisional pain

研究概览

简要总结

Regional block of ilioinguinal and iliohypogastric (IIIH) nerves has been applied to provide postoperative analgesia after inguinal hernia repair. Magnesium sulfate (MgSo4) blocks N-methyl-d-aspartate receptors, and that is why, it was used as an adjuvant to the local anesthetic (LA) in different anesthetic approaches. Although the prolongation in postoperative duration resulting from the addition of MgSO4 to LA was significant in some literature studies, it was insignificant in others. This study was designed to investigate the adjunctive effect of MgSo4 when added to bupivacaine for IIIH blockade on the postoperative analgesic duration as a primary outcome and on the verbal rating scale (VRS) scores, analgesic consumption, and hemodynamics as secondary outcomes.

详细描述

Regional block of ilioinguinal and iliohypogastric (IIIH) nerves has been applied to provide postoperative analgesia after inguinal hernia repair. Magnesium sulfate (MgSo4) blocks N-methyl-d-aspartate receptors, and that is why, it was used as an adjuvant to the local anesthetic (LA) in different anesthetic approaches. Although the prolongation in postoperative duration resulting from the addition of MgSO4 to LA was significant in some literature studies, it was insignificant in others. This study was designed to investigate the adjunctive effect of MgSo4 when added to bupivacaine for IIIH blockade on the postoperative analgesic duration as a primary outcome and on the verbal rating scale (VRS) scores, analgesic consumption, and hemodynamics as secondary outcomes. Patients were divided into two groups of 45 patients each by means of coded envelopes according to the LA used for IIIH blockade. In the first group (control group), patients received 10 ml 0.5% isobaric bupivacaine plus 1 ml normal saline for IIIH blockade, whereas in the second group (MgSo4 group), 10 ml 0.5% isobaric bupivacaine and 1 ml of MgSo4 10% were prepared. All the patients received intrathecal 3 ml 0.5% hyperbaric bupivacaine, and then, IIIH blockade was performed under ultrasound guidance according to the group. Postoperatively, VRS scores,analgesic duration, and any complication were recorded.

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
Double (Care Provider, Outcomes Assessor)

入排标准

性别
Male
接受健康志愿者

入选标准

  • Adult male
  • American Society of Anesthesiologists physical status I or II

排除标准

  • Patients with body mass index greater than or equal to 35 kg/m2
  • allergy to the study drugs
  • on chronic analgesics or drug containing magnesium

研究组 & 干预措施

control group

Placebo Comparator

10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade

干预措施: normal saline (Other)

MgSo4 group

Active Comparator

10 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used.

干预措施: MgSo4 (Drug)

结局指标

主要结局

Postoperative incisional pain

时间窗: 24 hours postoperatively

Postoperative incisional pain was evaluated by VRS

次要结局

未报告次要终点

研究者

发起方
Abdelrady S Ibrahim, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Abdelrady S Ibrahim, MD

Professor Of Anesthesia and ICU

Assiut University

研究点 (1)

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