The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Other: Placebo; Drug: Ibuprofen; Drug: Morphine; Drug: Zofran; Drug: Paracetamol; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01953978

SM-RS-2012

2012-004181-18 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing lumbar disc surgery in general anaesthesia.
• Patients who have given their written consent to participate and understand the contents of the protocol.
• ASA 1-3.
• BMI > 18 og < 40.
• Fertile women need a negative HCG urine test.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Dexamethasone

Active Comparator group

Description:

* 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.

Treatment:

Drug: Ibuprofen

Drug: Morphine

Drug: Dexamethasone

Drug: Zofran

Drug: Paracetamol

Placebo

Placebo Comparator group

Description:

* 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.

Treatment:

Drug: Ibuprofen

Drug: Morphine

Other: Placebo

Drug: Zofran

Drug: Paracetamol