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临床试验/NCT03529201
NCT03529201已完成不适用

Effectiveness of Quadratus Lumborum Block After Nephrectomy

Medical University of Lublin2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年5月7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
已完成
入组人数
105
试验地点
2
主要终点
Total consumption of oxycodone

研究概览

简要总结

Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB).

详细描述

Patients undergoing nephrectomy procedures will be allocated to one of the study arms. At the end of an operation, still under general anesthesia, 50% patients will obtain QLB with ropivacaine.

Ultrasound-guided QLB will be performed on the side of surgery with 0.375% ropivacaine solution (0.2 mL per kg).

Every patient will get patient-controlled analgesia pump with oxycodone in the postoperative period.

Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of the operation. 24 -hours period.

At the 1, 3, 6 months patients will be interviewed by phone to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

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
Single (Participant)

盲法说明

A regional block will be performed under general anesthesia. Patients will not be aware of this procedure.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • obtained consent
  • nephrectomy procedure

排除标准

  • coagulopathy allergy to local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs

研究组 & 干预措施

QLB

Experimental

At the end of surgery, QLB with ropivacaine will be done on the side of the operation.

干预措施: Rocuronium (Drug)

QLB

Experimental

At the end of surgery, QLB with ropivacaine will be done on the side of the operation.

干预措施: QLB (Procedure)

QLB

Experimental

At the end of surgery, QLB with ropivacaine will be done on the side of the operation.

干预措施: PCA (Device)

QLB

Experimental

At the end of surgery, QLB with ropivacaine will be done on the side of the operation.

干预措施: GA (Procedure)

QLB

Experimental

At the end of surgery, QLB with ropivacaine will be done on the side of the operation.

干预措施: Oxycodone (Drug)

QLB

Experimental

At the end of surgery, QLB with ropivacaine will be done on the side of the operation.

干预措施: Sevoflurane (Drug)

QLB

Experimental

At the end of surgery, QLB with ropivacaine will be done on the side of the operation.

干预措施: Fentanyl (Drug)

Control

Experimental

Standard care. No regional blocks.

干预措施: PCA (Device)

Control

Experimental

Standard care. No regional blocks.

干预措施: GA (Procedure)

Control

Experimental

Standard care. No regional blocks.

干预措施: Oxycodone (Drug)

Control

Experimental

Standard care. No regional blocks.

干预措施: Sevoflurane (Drug)

Control

Experimental

Standard care. No regional blocks.

干预措施: Fentanyl (Drug)

Control

Experimental

Standard care. No regional blocks.

干预措施: Rocuronium (Drug)

结局指标

主要结局

Total consumption of oxycodone

时间窗: 24 hours after the end of surgery.

Overall use of oxycodone administered by PCA pump will be assessed.

次要结局

  • Pain intensity(24 hours after the end of surgery)
  • Chronic pain(6 months after the surgery)

研究者

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

Michał Borys

M.D., Ph.D.

Medical University of Lublin

研究点 (2)

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