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临床试验/NCT05964985
NCT05964985尚未招募不适用

Effect of Ultrasound-guided Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Postoperative Pain in Patients Undergoing Colorectal Surgery: a Randomized Double-blind Controlled Trial

Tianjin Medical University General Hospital0 个研究点目标入组 160 人开始时间: 2023年8月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
160
主要终点
Postoperative opioid consumption

研究概览

简要总结

Purpose:

To explore effects of ultrasound-guided quadratus lumborum block with compound lidocaine and esketamine on postoperative pain after colorectal surgery.

详细描述

Poor post-surgical pain control is a leading factor that hinders the physicalrehabilitation, and causes acute cognitive impairment and chronic painsyndrome. Recently, the multimodal analgesia strategies to minimise opioidrelated side effects are highly desirable in open surgical procedures. Quadratus lumborum block is a novel technique. Although ropivacaine is most commonly used forthis technique, the analgesic duration remains not dissatisfied. Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. However, whether compound lidocaine injection is efficiency in the quadratus lumborum block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided quadratus lumborum block (USG-QLB) with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal surgery.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject is scheduled to undergo colorectal cancer surgery under general anesthesia
  • Subject's American Society of Anesthesiologists physical status is I-III.
  • The subject's parent/legally authorized guardian has given written informed consent to participate

排除标准

  • Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
  • Subject has a diagnosis of Insulin dependent diabetes.
  • Subject is allergy and contraindication to local anesthetics or any components of local anesthetics.
  • Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
  • Subject has any contraindication for the use of patient-controlled analgesia (PCA).
  • Subject is pregnant or breast-feeding.
  • Subject is obese (body mass index >30kg/m^2).
  • Subject is incapacity to comprehend pain assessment and cognitive assessment.

研究组 & 干预措施

Normal saline in quadratus lumborum block

Placebo Comparator

After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.

干预措施: Normal saline (Drug)

Ropivacaine in quadratus lumborum block

Active Comparator

After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.

干预措施: Ropivacaine (Drug)

Compound lidocaine in quadratus lumborum block

Active Comparator

After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.

干预措施: Compound lidocaine (Drug)

Compound lidocaine and esketamine in quadratus lumborum block

Active Comparator

After the induction of anesthesia, 0.6% compound lidocaine and 0.4 mg/kg esketamine are used for bilateral quadratus lumborum block in a volume of 20 mL of each side.

干预措施: Compound lidocaine (Drug)

Compound lidocaine and esketamine in quadratus lumborum block

Active Comparator

After the induction of anesthesia, 0.6% compound lidocaine and 0.4 mg/kg esketamine are used for bilateral quadratus lumborum block in a volume of 20 mL of each side.

干预措施: Esketamine (Drug)

结局指标

主要结局

Postoperative opioid consumption

时间窗: 72 hours after surgery

Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing opioid in normal saline after leaving PACU (Postanesthesia care unit). Opioid cumulative consumption is recorded for 72 hours postoperatively.

次要结局

  • Pain Score (NRS)(72 hours after surgery)
  • Time of First Postoperative Analgesic Requirement(1 hour after surgery)
  • The incidence of Side Effects(72 hours after surgery)
  • The level of cytokines in blood By ELISA kits(72 hours after surgery)
  • The level of chemokines in blood By ELISA kits(72 hours after surgery)
  • Total Dose of First Postoperative Analgesic Requirement(1 hour after surgery)
  • Apfel score(The 1 day before the surgery)
  • Mean time until passage of flatus(96 hours after surgery)
  • Diffusion area of local anesthetics after quadratus lumborum block(30 minutes after quadratus lumborum block)
  • Normalized Area of Hyperalgesia Around the Incision(72 hours after surgery)

研究者

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

Guolin Wang

Professor

Tianjin Medical University General Hospital

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