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临床试验/NCT01472835
NCT01472835已完成不适用

Randomized, Cross-over Study Evaluating the Effect of Sedation on Pain Relief After Diagnostic Injections

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2011年3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
入组人数
73
试验地点
1
主要终点
Pain Score

研究概览

简要总结

Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is well-documented that the reference standard for identifying a pain generator is a low-volume block performed with local anesthetic, with or without steroid. Many factors may increase the false positive (FP) rate of diagnostic and prognostic nerve blocks; however, the use of sedation is the most controversial and remediable. Proponents of sedation argue that it has little effect on the rate of positive diagnostic blocks, and may even reduce the false-negative rate. The purpose of this study is to determine the effect of intravenous sedation on pain relief and the "false-positive rate" after diagnostic nerve blocks.

详细描述

Sixty-eight patients with sacroiliac (SI) joint or sympathetically-maintained pain will be randomized in a crossover fashion to receive diagnostic nerve blocks either with or without intravenous sedation. Among those who obtain some benefit and return for a 2nd block, this 2nd procedure will be done with sedation if the first was done without sedation, and vice versa. Midazolam and fentanyl will be used for intravenous sedation, titrated to anxiolysis and analgesia. Pain scores (0-10 numerical rating scale, or NRS) and an activity log will be recorded over the 8-hours following the blocks via a pain diary. The first follow-up visit will be 4 weeks after the procedure. Patients who obtain some benefit but continue to report significant pain or who might otherwise benefit from a repeat procedure will have this second procedure performed with sedation if no sedation was given for the first procedure, and without sedation if sedation was administered for the first procedure. The post-procedure pain data will be recorded in the same fashion as the initial nerve block. The second follow-up visit will be 4 weeks after the 2nd block.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic pain > 4 weeks but < 10 years in duration
  • Suspected SI joint or sympathetically-maintained pain based on history and physical exam
  • May benefit from a sacroiliac joint or sympathetic block
  • Pain on 0-10 NRS scale > 3/10 in intensity

排除标准

  • No previous interventional pain-alleviating injections for the same condition within the past 3 years
  • Uncontrolled coagulopathy
  • Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age
  • Allergy to contrast dye or amide local anesthetics
  • Unstable medical or psychiatric condition (e.g. unstable angina, congestive heart failure or severe depression) that could preclude an optimal treatment response
  • Systemic infection
  • Age < 18 or > 75 years

研究组 & 干预措施

Sedation

Experimental

Pt will receive sedation with their procedure

干预措施: Midazolam (Drug)

Sedation

Experimental

Pt will receive sedation with their procedure

干预措施: Fentanyl (Drug)

结局指标

主要结局

Pain Score

时间窗: through 6 hours after injection

pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable

次要结局

  • Procedure-related Pain Score(1 day)
  • Oswestry Disability Index(1-month)
  • Satisfaction(1 day)
  • Pain Score(1-month)

研究者

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

Steven P. Cohen

Professor

Johns Hopkins University

研究点 (1)

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