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临床试验/NCT03035656
NCT03035656Unknown4 期

Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion

Horizon Health Network0 个研究点目标入组 228 人开始时间: 2019年3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
入组人数
228
主要终点
Change in Pain

研究概览

简要总结

The following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single intra-operative epidural injection of Ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2) Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if there are differences in pain management between MIS and open surgical procedures. The proposed study will add novel information to current knowledge by 1) exploring of the effects of intra-operative single epidural injection analgesic on patients receiving MIS compared to open surgery, and 2) investigate potential immediate and short-term functional improvements gained from intra-operative single injection of Ropivaciane®.

详细描述

This double blinded, randomized clinical trial will test hypotheses by administering a single epidural injection prior to wound closure of either Ropivaciane® or saline.All pre-surgical activities and anesthesia will proceed as usual, with the addition of a single epidural injection immediately prior to wound closure 2 levels, or 10cm above the operated spinal level. Experimental groups will receive 0.2% Ropivaciane® (10 ml; dose shown to be effective without transient weakness), 9 and the control group will receive 0.9% saline solution (10 ml). Accurate placement into the space will be verified by the injection of contrast medium (iohexol, 180 mgl/ml) under fluoroscopic guidance. Epidural solutions will be prepared prior to surgery by pharmacy and coded; surgeons will administer according to the patient's code maintaining the double-blind procedure. It is important to note that treatment as usual differs between open and MIS cohorts. The question of interest is whether the addition of the epidural analgesic to current practices for each surgery type results in increased positive outcomes, whether this is due to synergistic effects or not. Following operative treatment, Foley Urinary catheter will be removed 24 hours post-operatively, unless otherwise clinically indicated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Randomization of arms are conducted by the pharmacy department, and drug or saline preparation are prepared by the pharmacy department.

入排标准

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

入选标准

  • Consenting participants undergoing elective 1-2 level lumbar fusion through the Canada East Spine Centre

排除标准

  • History of severe respiratory, renal or hepatic disease
  • Previous spine surgery
  • Known allergy to local anaesthesia
  • Those who experience dural tear during operative procedure

研究组 & 干预措施

Experimental

Experimental

Administration of epidural Ropivaciane

干预措施: Ropivacaine (Drug)

Control

Placebo Comparator

Administration of saline

干预措施: Saline (Other)

结局指标

主要结局

Change in Pain

时间窗: Administered 6 weeks pre-operatively, 2, 4, 8, 12, 24 and 48 hours post-operatively, 6 months post operatively, and 12 months post operatively

Back and leg pain measured using the validated Numeric Rating Scales (NRS) for back and leg pain.

次要结局

  • Change in Medication Use(Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.)
  • Change in General Health(Administered 6 weeks pre-operatively, 6 and 12 months post-operatively)
  • Change in Disability(Administered 6 weeks pre-operatively, 6 and 12 months post-operatively)

研究者

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

Dr. neil Manson

Principal Investigator

Horizon Health Network

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