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临床试验/NCT05371015
NCT05371015已完成不适用

Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
Pain associated with uterine contractions

研究概览

简要总结

With the continuous advancement of ultrasonic technology, nerve block in which drugs are injected into the periphery of the target nerve through ultrasonic guidance has become the mainstream method for postoperative pain control. The quadratus lumborum nerve block has been effectively and safely used in abdominal surgery (such as laparotomy, caesarean section, etc.), effectively reducing postoperative wounds and visceral pain. There is no research on the use of quadratus lumborum nerve block to control the pain of natural postpartum uterine contractions in the current literature, so the purpose of this experiment is to explore whether the quadratus lumborum nerve block can effectively reduce the pain of uterine contractions after vaginal delivery.

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, Investigator, Outcomes Assessor)

盲法说明

After the computer program (SAS® 9.4) generates the groups of subjects in random order, a third-party person who is not the research team will put the groups into envelopes numbered one to one hundred in sequence. Which group the subjects will be assigned to will not be known to members of the research team until the trial is unblinded.

入排标准

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

入选标准

  • •Females over twenty years of age
  • •Maternal vaginal delivery
  • •Postpartum moderate to severe pain with uterine contractions (Numerical Pain Scale (NRS) ≥ 4 points) after delivery.
  • •Subject's consent signed by the subject

排除标准

  • •Severe coagulation abnormalities (PLT<100000、INR>1.2、PT>13)
  • •Infection of the epidermis at the anticipated relevant site of injection
  • •Allergy to local anesthetics
  • •Allergy to or abuse of pain control medications
  • •Episiotomy is more painful than uterine contractions
  • •Inability to cooperate with associated pain assessment
  • •Body Mass Index (BMI) ≧ 35 kg/m2

研究组 & 干预措施

quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine)

Experimental

The subjects would have quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine) after vaginal delivery.

干预措施: quadratus lumborum nerve block (ropivacaine ) (Procedure)

quadratus lumborum nerve block with normal saline

Placebo Comparator

The subjects would have quadratus lumborum nerve block with normal saline after vaginal delivery.

干预措施: quadratus lumborum nerve block (normal saline) (Procedure)

结局指标

主要结局

Pain associated with uterine contractions

时间窗: 48 hours after intervention

Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]

Pain associated with uterine contractions

时间窗: Right before intervention

Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]

Pain associated with uterine contractions

时间窗: 1 hour after intervention

Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]

Pain associated with uterine contractions

时间窗: 6 hours after intervention

Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]

Pain associated with uterine contractions

时间窗: 12 hours after intervention

Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]

Pain associated with uterine contractions

时间窗: 24 hours after intervention

Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]

Pain associated with uterine contractions

时间窗: 36 hours after intervention

Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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