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临床试验/NCT05348083
NCT05348083已完成不适用

Bilateral Erector Spinae Plane Block (ESPB) Versus Posterior Quadratus Lumborum Block (p-QLB) for Postoperative Analgesia After Caesarean Section: an Observational Closed Mixed Cohort Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Opioid consumption at 24 h

研究概览

简要总结

Management of pain after caesarean section represents an important anesthesiologic issue, since it is often suboptimal, leading to delayed functional recovery and chronic pain. Currently, the postoperative analgesic strategy mostly relies on intrathecal morphine (ITM) and multimodal analgesic regimen. Recently, the need for alterative opioid sparing techniques is emerging. Paraspinal fascial plane blocks, as quadratus lumborum block (QLB) and erector spinae plane block (ESPB) performed at T9 level, have therefore been proposed as alternatives to ITM, because of their demonstrated effect on visceral and somatic pain.

The aim of the study is to assess the efficacy, the feasibility and safety of bilateral ESPB compared to bilateral QLB for the management of postoperative pain after ceasarean section conducted under spinal anesthesia without ITM.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Patients ASA 2 with normal singleton pregnancy, scheduled for elective caesarean section without intrathecal morphine, who underwent bilateral ESPB at the end of surgery an who gave informed consent to data collection.

排除标准

  • Contraindications to spinal anesthesia;
  • Contraindications to or a history of opioid dependence;
  • Allergy to local anesthetics, acetaminophen, NSAIDs
  • Inability to understand pain assessment scales or to use Patient Controlled Analgesia (PCA) pump;
  • Patient refusal.

结局指标

主要结局

Opioid consumption at 24 h

时间窗: 24 hours from block performance

Total morphine consumption at 24 hours from block performance

次要结局

  • Intensity of pain at time of block performance(Time of block performance, at the end of surgery)
  • Intensity of pain at 6 hours(6 hours from block performance)
  • Time to first opioid request(Any time during the first 24 hours from block performance)
  • Differences in hemodynamic parameters(Any time during the first 24 hours from block performance)
  • Intensity of pain at 2 hours(2 hours from block performance)
  • Intensity of pain at 12 hours(12 hours from block performance)
  • Intensity of pain at 24 hours(24 hours from block performance)
  • Adverse events(Any time during the first 24 hours from block performance.)

研究者

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

ZANFINI BRUNO ANTONIO

Physician Anesthesiologist

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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