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临床试验/NCT04447950
NCT04447950Unknown不适用

A Randomized, Double Blind, Placebo Controlled Evaluation Trial of the Benefit in Quadratus Lumborum Block as a Postoperative Analgesic Technique for a Lumbar Spine Decompression and Fusion Surgery

Assuta Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Change in the use of post-operative narcotics

研究概览

简要总结

Lumbar spinal decompression and fusion is a commonly performed procedure fro neural impingement and back pain from a variety of pathologies. The importance of pain control in the postoperative period for spinal surgery has been discussed and proven extensively, with both immediate and delayed reduction in complications and improved clinical results.

Quadratus lumborum (QL) block was introduced in 2007 and is performed under ultrasound guidance for perioperative pain management in various surgeries.However, the plane for a posterior QL block can be easily reached during open midline spinal surgery.

The investigators hypothesize that the posterior QL block is an effective analgesic tool for lumbar laminectomy surgery, because in lumbar laminectomy the quadratus lumborum is already exposed and is in direct visual contact. For that reason it is imperative to test the benefits of this procedure.

This is a double blinded randomized control study to assess the results of intra-operative QL block performed for lumbar decompression and fusion.

详细描述

Spinal decompression is a surgical procedure that is performed to alleviate pain caused by pinched nerves (neural impingement). Surgical options for decompressing the lumbar spine vary from minimally invasive disc decompression to open laminectomy and foraminotomy. The lumbar spine decompression and fusion differs from a microdiscectomy in that the incision is longer and there is more muscle stripping. Lumbar spinal decompression is a commonly performed procedure and the conventional open techniques of decompression remain the gold standard of treatment.

During a lumbar decompression back surgery, a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed to give the nerve root more space and provide a better healing environment. A lumbar spine decompression and fusion is typically performed to relieve the lumbar spinal stenosis symptoms. The goal of the surgery is to allow more space for the nerve root, thus reducing pain (and potentially any leg weakness or neurological symptoms) and restoring the patient's ability to participate in everyday activities[1].

Quadratus lumborum (QL) block was introduced in 2007 and is performed for perioperative pain management in various abdominal, pelvic, gynecological and hip procedures in all age groups[2]. Four types of QL block were described, differentiated by the exact location of the anesthetic injection. Type 1/lateral QL block is performed at the lateral border of the QL muscle, type 2/posterior QL block is performed at the medial edge of the QL muscle (at the border or the spine erector muscles and the thoraco-lumbar fascia), type 3/anterior is performed between the QL muscle and the psoas major and type 4 is intramuscular (see figure 1). In the majority of cases, these blocks are performed pre/post operatively under ultrasound guidance. There are sporadic reports of QL block performed for lumbar spinal surgery [3, 4].However, the plane for a type 2 QL block can be easily reached during open midline spinal surgery.

The importance of pain control in the postoperative period for spinal surgery has been discussed and proven extensively, with both immediate and delayed reduction in complications and improved clinical results [5, 6].

The investigators hypothesize that the type 2 QL block is an effective analgesic tool for lumbar laminectomy surgery, because in lumbar laminectomy the quadratus lumborum is already exposed and is in direct visual contact. For that reason it is imperative, in our opinion, to test its benefits of this procedure.

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)

盲法说明

Rotating nurse assigning the arm, scrubbed nurse preparing syringe for injection with a clear liquid - saline vs saline and Marcaine, surgeon blinded to type of liquid in syringe.

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

  • Men and women at the ages of 18-80 suffering from leg + back pain or neurological claudication.
  • Undergoing an elective 1-3 level lumbar laminectomy & fusion at Assuta medical center.

排除标准

  • Chronic narcotic treatment (more than 3 months)
  • Current active Infection.
  • Underwent any other major operation in the last two months.
  • Known hypersensitivity to local anaesthetic
  • Previous lumbar instrumentation (revision of decompression to decompression with fusion will be included)
  • Non Ambulatory patients

结局指标

主要结局

Change in the use of post-operative narcotics

时间窗: Will be reported for each postoperative day during the inpatient stay of the patient to a maximum of 7 days.

Difference in MME (morphine milligrams equivalent) of inpatient narcotics consumption.

次要结局

未报告次要终点

研究者

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

Ely Ashkenazy

Dr Ely Ashkenazy, neurosurgeon

Assuta Medical Center

研究点 (2)

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