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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborator: Glostrup University Hospital, Copenhagen
• Treatments: Acetaminophen; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ibuprofen; Morphine; Ondansetron

Criteria

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.