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临床试验/NCT03428880
NCT03428880已完成4 期

Ultrasound Guided Quadratus Lumborum Type III Block Versus Intrathecal Morphine for Analgesia After Cesarean Delivery

University Tunis El Manar2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年2月15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
发起方
入组人数
120
试验地点
2
主要终点
Total morphine consumption over 24 hours postoperatively

研究概览

简要总结

Subarachnoid morphine (SAM) is the gold standard for treating postoperative pain after cesarean delivery (CD) but it has undesirable side effects, that's why the aim of our study is to identify whether ultrasound-guided Quadratus lumborum block type 3, a new regional anesthetic technique that blocks the abdominal wall neural afferents, can provide at the same time better postoperative analgesia after CD with less side effects

详细描述

In this prospective double blinded randomized study,120 parturients undergoing cesarian delivery via a Pfannenstiel incision and who agreed to spinal anesthesia were randomly scheduled to receive either a SAM (group SAM, n=60) or a Quadratus lumborum block type 3 (group QLB, n=60).Spinal anesthesia was initiated with hyperbaric Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 0.1 mg morphine in the SAM group and with Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 1 ml normal saline in group QLB.

After surgery, bilateral QLB block type 3 was performed with the patient in lateral position using bupivacaine 0.25% , 20 mL on each side in group QLB and 20 ml normal saline in group SAM.

Postoperative analgesia for the first 24 hours consisted of a patient controlled analgesia with IV morphine only. If necessary breakthrough pain was treated by 01 g paracetamol intravenously by the same doctor in charge of taking the values of the visual analogue scale.

Patients were assessed postoperatively in the postanesthesia care unit (time 0 hours) and at 2, 4, 6, 12 and 24 hours.

Visual analogue scale (VAS) for pain at rest and during the palpation of the uterine globe was noted.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA I/II.
  • Normal singleton pregnancy with a gestation of at least 37 weeks.

排除标准

  • Heart disease
  • Coagulopathy
  • pre-eclampsia
  • Patient refusal to undergo the Quadratus lumborum block.
  • Allergy to local anesthetics

研究组 & 干预措施

spinal morphine

Active Comparator

intrathecal morphine with 10 mg bupivacaine, 5 gamma sufenta and 100 gamma morphine. Intervention: In the end of surgery a QLB block is done with 20 ml of normal saline per side.

干预措施: Morphine (Drug)

quadratus lumborum block

Active Comparator

intrathecal anesthesia with10 mg bupivacaine, 5 gamma sufena and 1 ml normal saline.

Procedure : a quadratus lumborum block is done with 20 ml of bupivacaine 0,125% per side.

干预措施: Quadratus lumborum block (Drug)

结局指标

主要结局

Total morphine consumption over 24 hours postoperatively

时间窗: Arrival to post anesthesia care unit until 24 hours posteratively

Total IV morphine used when started postoperatively using a PCA with morphine in the post anesthesia care unit until 2' hours posteratively.

次要结局

  • Time to first analgesic demand using PCA pump with morphine(Arrival to post anesthesia care unit until 24 hours posteratively)
  • Visual analog scale (VAS) pain scores at rest and during the palpation of the uterine globe(Arrival to post anesthesia care unit until 24 hours posteratively)
  • Time to first deambulaton after surgery(Arrival to post anesthesia care unit until 24 hours posteratively)

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ben marzouk Sofiene

MD, assistant professor

University Tunis El Manar

研究点 (2)

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