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临床试验/NCT01513564
NCT01513564已完成不适用

Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery

Northern Orthopaedic Division, Denmark1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2001年1月最近更新:
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
发起方
入组人数
120
试验地点
1
主要终点
Multimodal management of lumbar fusion

研究概览

简要总结

Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery accelerated stay programs with optimized pain management enhance recovery.

The objective is to evaluate the effect of a revised and optimized perioperative fast track program in lumbar fusion surgery.

详细描述

Major spine surgery is usually associated with high postoperative pain scores and opioid requirements. Epidural analgesia has been reported to be an effective and safe method to control postoperative pain after spinal instrumentation surgery, but the overall effects of pain management on postoperative length of stay and recovery remains debatable.

However, in a multimodal approach, including multimodal non-opioid analgesia to control postoperative pathophysiology and rehabilitation, complications and hospital stay have been reduced after arthroscopy, hip arthroplasty and knee arthroplasty, hip fractures and abdominal surgery and other procedures, when combined with an enhanced recovery program.

The aim of the study is to assess the effect and safety of a combined analgesic regimen consisting of local anesthetic, intra-operative and post-operative continuous epidural analgesia and a single dose ketorolac together with a fast track rehabilitation program after 360 degree lumbar fusion for degenerative disc disease and spondylolisthesis < 2

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Degenerative disc disease and Spondylolisthesis up to grade 2 at one to the three lower lumbar levels.

排除标准

  • Previous fusion, metabolic bone disease, severe comorbidity or psychological instability.

研究组 & 干预措施

Conservative treatment program

Experimental

The control group were supervised isometric passive and active exercises by a physiotherapist. On the second day patients were allowed to sit in a chair being instructed to a low intensity exercise training program with regard to back pain and fear of activity. From the third or fourth day stair training, low intensity exercise, daily walks and instruction in home training were allowed.

The intervention group received the same training program but with a faster program plus a higher intensity exercise-training program.

干预措施: Postoperative epidural morphine (Drug)

Conservative treatment program

Experimental

The control group were supervised isometric passive and active exercises by a physiotherapist. On the second day patients were allowed to sit in a chair being instructed to a low intensity exercise training program with regard to back pain and fear of activity. From the third or fourth day stair training, low intensity exercise, daily walks and instruction in home training were allowed.

The intervention group received the same training program but with a faster program plus a higher intensity exercise-training program.

干预措施: Local anaesthesia (Drug)

结局指标

主要结局

Multimodal management of lumbar fusion

时间窗: Two years

Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index

次要结局

  • Multimodal management of lumbar fusion(Two years)

研究者

发起方
Northern Orthopaedic Division, Denmark
申办方类型
Other
责任方
Sponsor

研究点 (1)

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