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临床试验/NCT05092828
NCT05092828Unknown4 期

Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery: A Prospective, Randomized Clinical Controlled Trial

Sonoran Spine Research and Education Foundation2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
40
试验地点
2
主要终点
Pain and Outcome Assessment

研究概览

简要总结

This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.

详细描述

Background Deformity surgery is considered one of the most painful procedures patients can undergo in medicine today. Stringent protocols for pain management have done much to dramatically increase patient satisfaction, but the procedure still lags considerably behind advances in pain control when compared to other procedures such as total joint surgery. Specifically, it has been reported that over half of patients undergoing spine surgery report inadequate pain control the first 24 hours after surgery. Uncontrolled pain has been shown to correlate with prolonged hospital stays, delayed ambulation, poor functional outcomes, and increased risk for the development of chronic pain. Furthermore, the large amount of narcotics given to patients in an attempt to mitigate their pain postoperatively often leads to significant complications in their own right, such as ileus, mental status changes, and nausea. New modalities to treat postoperative pain, especially in the initial days following deformity correction, are needed.

Intrathecal (subarachnoid) injection of morphine has been used to treat severe pain since the 1970's. Its efficacy in treating postoperative pain has been well documented in various specialties including obstetrics, oncology, general surgery, and orthopedic surgery. Specific to spine surgery, intrathecal morphine is an attractive option given the access and visualization of the thecal sac in addition to the high demand of pain control required postoperatively. However, there remains no definitive consensus regarding the use of intrathecal morphine in spine surgery. Current literature is limited by few randomized trials, small sample sizes, heterogeneity of outcomes recorded, and an unclear association with complications. Additionally, there is a paucity of data dedicated to patients undergoing deformity correction. Accordingly, there is a need for high-quality trials to investigate the role of intrathecal morphine in adult spinal deformity surgery.

In this study, we hypothesized that the use of intrathecal morphine will significantly reduce post-operative pain after deformity surgery, reduce opioid utilization, decrease hospital stay, allow for earlier ambulation, increase patient satisfaction, and have comparable complications to traditional pain management strategies. This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.

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
Double (Participant, Outcomes Assessor)

盲法说明

Nursing staff and physical therapists will be blinded to intrathecal morphine utilization as to not bias the input of these variables

入排标准

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

入选标准

  • Adult patients 18 years and older with a diagnosis of adult or degenerative scoliosis,
  • Patients meeting criteria for surgical correction involving back and/or leg pain
  • Fusion of 4+ levels,
  • Competency to undergo informed consent process,
  • Medical clearance for spinal fusion surgery,

排除标准

  • Patients with lumbar spine inaccessible for intrathecal Duragesic (fused L2-S1)
  • Patients undergoing 3 or less levels of fusion
  • Patients with neuromuscular disease
  • Opioid intolerance or dependence
  • Severe coexisting diseases

研究组 & 干预措施

Study Group

Active Comparator

Patients in this group will receive intrathecal morphine in addition to standard post-operative pain medications

干预措施: Intrathecal Morphine Injection (Drug)

Control Group

Active Comparator

Patients in this group will receive standard post-operative pain medications but will not receive intrathecal morphine

干预措施: Pain Relieving (Drug)

结局指标

主要结局

Pain and Outcome Assessment

时间窗: 2-year follow up

postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

次要结局

  • Pain medications(2 year Post Operative)

研究者

发起方
Sonoran Spine Research and Education Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Chang, MD

Clinical Associate Professor

Sonoran Spine Research and Education Foundation

研究点 (2)

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