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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
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.
Glostrup University Hospital
Glostrup Municipality, Denmark
Painscore during mobilization
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.
Time frame: 2-24 hours after extubation time.
Painscore during rest
Painscore during rest (VAS scale) at time 2, 4, 8, 12 and 24 hours, calculated as area under curve (AUC) from 2-24 hours after extubation time.
Time frame: 2-24 hours after extubation time
Morphine consumption
Total morphine consumption 0-24 hours after extubation time, administered as patient controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes).
Time frame: 0-24 hours after extubation time.
Painscore during rest and mobilization
Painscore during rest and during active mobilization (VAS scale) at time 48 hours after extubation time.
Time frame: 48 hours after extubation time
Degree of nausea
Degree of nausea 2, 4, 8, 12, 24 and 48 hours after extubation time
Time frame: 2, 4, 8, 12, 24 and 48 hours after extubation time
Incidence of vomiting
Total number of vomits 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.
Time frame: 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.
Zofran consumption
Consumption of Zofran (milligram) 0-24 and 24-48 hours after extubation time.
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Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
Tablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
Tablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
Time frame: 0-24 and 24-48 hours after extubation time.
Degree of sedation
Degree of sedation 2, 4, 8, 12, 24 and 48 hours after extubation time.
Time frame: 2, 4, 8, 12, 24 and 48 hours after extubation time.
Quality of sleep
Quality of sleep 24 hours after extubation time.
Time frame: 24 hours after extubation time.