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临床试验/NCT01371422
NCT01371422终止不适用

Randomized Controlled Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy

University of British Columbia1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2011年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

This is a randomized control trial (meaning the selection is random as when flipping a coin) to assess the benefit of paravertebral blockade (PVB) in Percutaneous nephrolithotomy/nephrolithotripsy (PCNL) surgery.

详细描述

Percutaneous nephrolithotomy/nephrolithotripsy (PCNL) is an effective treatment that offers maximal physical removal of large kidney stones. However, despite the minimally invasive nature of the procedure, postoperative pain still remains a significant concern. General anaesthetic (solution given to put the patient to sleep) for the procedure is routinely given, along with a local anaesthetic injection at the operative site (injection of anaesthetic solution to the incision area to reduce the pain after the procedure) and pain pills to reduce the pain even further after surgery. Paravertebral nerve blockade (PVB) is a technique for inserting anesthetic solution into an area near the vertebrae (bony segments that form the spinal column of humans or backbone), and is an effective method for reducing pain in the post operative period from a variety of surgeries.

The investigators expect that the PVB can decrease side effects from opioids (pain medication) and other analgesics used post-operatively. Opioid side effects include nausea, vomiting, urinary retention, constipation, and drowsiness. Other side effects associated with anaesthetic use include peptic ulcer disease and acute renal failure. The investigators also expect that PVB will result in decreased post-operative pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •19 or older, able to give consent
  • •ASA 1, 2 or 3 patients
  • •Patients to undergo PCNL

排除标准

  • •Complex stone with anticipation of requiring >1 access sites
  • •Prior diagnosis of chronic pain requiring daily opioid analgesia for > 1 month prior to diagnosis of Nephrolithiasis
  • •Allergy to local anesthetic
  • •Local infection at site of regional anesthesia
  • •Back or other MSK deformity that contributes to inaccuracy of paravertebral block placement
  • •Severe cardiopulmonary disease
  • •Fibromyalgia
  • •Anticoagulation
  • •Patient with language barrier or inability to communicate

研究组 & 干预措施

A1 (PVB)

Experimental

PVB technique will be utilized for injection of the anaesthetic under the skin before the procedure.

干预措施: Paravertebral Block (PVB) (Other)

A2 (Placebo)

Placebo Comparator

The placebo is an inactive substance that looks identical to the test intervention but contains no active ingredients and will be administered the same as the PVB by a local skin injection, but no advancement of the needle to the paravertebral space will be made to avoid unnecessary risks.

干预措施: Saline (Other)

结局指标

主要结局

Opioid consumption

时间窗: 24 hours post-operative, one week post-operatively

次要结局

  • Postoperative pain measured by a visual analogue scale, length of hospital stay, and follow-up for the post operative course for complications(1, 6, and 24 hours post-operatively)

研究者

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

Ben Chew, MD

Associate Professor

University of British Columbia

研究点 (1)

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