NCT01933542已完成4 期
The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Painscore during mobilization
研究概览
简要总结
Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing spine surgery in general anaesthesia.
- •Postoperative pain > 50 mm on the VAS scale during mobilization.
- •Patients who have not received analgesia 1 hour prior to inclusion.
- •BMI > 18 og <
- •Fertile women need a negative HCG urine test.
- •Patients who have given their written consent to participate and understand the contents of the protocol.
排除标准
- •Participation in another clinical trial.
- •Patients who do not speak and/or understand Danish.
- •Fertile women with a positive HCG urine test.
- •Allergy to the drugs used in the trial.
- •Alcohol or medicine abuse, assessed by investigator.
- •Daily use of strong opioids (morphine, ketobemidone, oxynorm, methadone, fentanyl)
- •Daily chlorzoxazone treatment.
- •Known or suspected porphyria.
研究组 & 干预措施
Chlorzoxazone
Active Comparator
- Oral administration of chlorzoxazone 500 mg (two 250 mg tablets)
- Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
- Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
干预措施: Chlorzoxazone (Drug)
Chlorzoxazone
Active Comparator
- Oral administration of chlorzoxazone 500 mg (two 250 mg tablets)
- Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
- Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
干预措施: Morphine (Drug)
Chlorzoxazone
Active Comparator
- Oral administration of chlorzoxazone 500 mg (two 250 mg tablets)
- Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
- Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
干预措施: Zofran (Drug)
Placebo
Placebo Comparator
- Oral administration of two placebo tablets
- Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
- Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
- Oral administration of two placebo tablets
- Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
- Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
干预措施: Morphine (Drug)
Placebo
Placebo Comparator
- Oral administration of two placebo tablets
- Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
- Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
干预措施: Zofran (Drug)
结局指标
主要结局
Painscore during mobilization
时间窗: 2 hours after taking the trial medication
Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside
次要结局
- Degree of dizziness(1, 2, 3 and 4 hours after taking the trial medication)
- Morphine consumption(0-4 hours after taking the trial medication)
- Painscore during rest(1, 2, 3 and 4 hours after taking the trial medication)
- Painscore during mobilization(1, 2, 3 and 4 hours after taking the trial medication)
- Degree of nausea(1, 2, 3 and 4 hours after taking the trial medication)
- Zofran consumption(4 hours after taking the trial medication)
- Incidence of vomiting(0-4 hours after taking the trial medication)
- Degree of sedation(1, 2, 3 and 4 hours after taking the trial medication)
研究者
Rikke Vibeke Nielsen, MD
MD
Rigshospitalet, Denmark
研究点 (1)
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