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临床试验/2024-519617-56-00
2024-519617-56-00招募中2 期

Magnesiumsulphate for Postoperative Analgesia In the Newly delivered, The MAG-PAIN randomized controlled trial.

Region Halland1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年3月17日最近更新:
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
150
试验地点
1
主要终点
Acute postoperative pain within 6 hours

研究概览

简要总结

The aim in this study is to investigate if adding intravenous magnesium-sulfate to pregnant women undergoing cesarean section can lead to improved postoperative pain outcomes.

研究设计

分配方式
Randomized
主要目的
Magnesiumsulphate for Postoperative Analgesia In the Newly delivered
盲法
Single (Investigator, Subject)

入排标准

年龄范围
18 years 至 64 years(18-64 Years)
性别
Female
接受健康志愿者

入选标准

  • Adult over age
  • Cesarean section under spinal anesthesia. Participant should be able to accomodate information in Swedish

排除标准

  • Cronic kidney desease stadium 3 or above. Not Swedish speaking. Contraindication towards spinal anesthesia. General anesthesia

研究组 & 干预措施

-

Active Comparator

Participants receiving -

干预措施: - (Drug)

结局指标

主要结局

Acute postoperative pain within 6 hours

Acute postoperative pain within 6 hours

次要结局

  • Acute postoperative pain after 14 days, in both rest and movement.
  • Acute postoperative pain after 24 hours, in both rest and movement
  • Persistent postoperative pain after 3 months in both rest and movement.
  • Early recovery after 24 hours
  • Early recovery after 14 days.
  • Opioidconsumption. Total opioid dose in intravenous morphine milligram equivalents after 24 hours.
  • Postoperative nausea and vomiting. Highest intensity after 24 hours.
  • Self-evaluated quality of breastfeeding and fetal connection. Highest score between 0 and 10 is compared between groups after 24 hours.
  • Self-evaluated quality of breastfeeding and fetal connection. Highest score between 0 and 10 is compared between groups after 14 days.

研究者

申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Krister Mogianos

Scientific

Region Halland

研究点 (1)

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