NCT01953978已完成4 期
The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc 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
- 160
- 试验地点
- 1
- 主要终点
- Painscore during mobilization
研究概览
简要总结
The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
详细描述
The analgesic effect of dexamethasone is not well described, but studies have shown that an intermediate dosis of dexamethasone (0.11-0.2 mg/kg) can be a safe part of a multimodal analgesic strategy after surgery. Dexamethasone has an opioid-sparing effect and reduces pain during rest and mobilisation. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after herniated disk surgery. Our hypothesis is that dexamethasone 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 lumbar disc surgery in general anaesthesia.
- •Patients who have given their written consent to participate and understand the contents of the protocol.
- •BMI > 18 og <
- •Fertile women need a negative HCG urine test.
排除标准
- •Patients who cannot cooperate to the study.
- •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.
- •Patients who have had spine surgery before.
- •Daily use of strong opioids (morphine, ketobemidone, oxynorm, methadone, fentanyl)
- •Daily oral steroid treatment.
研究组 & 干预措施
Dexamethasone
Active Comparator
- Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
- 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
- Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
干预措施: Dexamethasone (Drug)
Dexamethasone
Active Comparator
- Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
- 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
- Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
干预措施: Morphine (Drug)
Dexamethasone
Active Comparator
- Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
- 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
- Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
干预措施: Zofran (Drug)
Dexamethasone
Active Comparator
- Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
- 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
- Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
干预措施: Paracetamol (Drug)
Dexamethasone
Active Comparator
- Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
- 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
- Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
干预措施: Ibuprofen (Drug)
Placebo
Placebo Comparator
- Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation
- 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
- Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
干预措施: Placebo (Other)
Placebo
Placebo Comparator
- Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation
- 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
- Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
干预措施: Morphine (Drug)
Placebo
Placebo Comparator
- Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation
- 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
- Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
干预措施: Zofran (Drug)
Placebo
Placebo Comparator
- Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation
- 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
- Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
干预措施: Paracetamol (Drug)
Placebo
Placebo Comparator
- Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation
- 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
- Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Painscore during mobilization
时间窗: 2-24 hours after extubation time.
Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside at time 2, 4, 8, 12 and 24 hours, calculated as area under curve (AUC) from 2-24 hours after extubation time.
次要结局
- Morphine consumption(0-24 hours after extubation time.)
- Incidence of vomiting(0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.)
- Degree of sedation(2, 4, 8, 12, 24 and 48 hours after extubation time.)
- Painscore during rest(2-24 hours after extubation time)
- Painscore during rest and mobilization(48 hours after extubation time)
- Zofran consumption(0-24 and 24-48 hours after extubation time.)
- Degree of nausea(2, 4, 8, 12, 24 and 48 hours after extubation time)
- Quality of sleep(24 hours after extubation time.)
研究者
Rikke Vibeke Nielsen, MD
MD
Glostrup University Hospital, Copenhagen
研究点 (1)
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