Clinical trial NCT01953978: The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery
Official title: The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Pain
Analgesia
Postoperative
Dexamethasone
Spine surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Glostrup University Hospital, Copenhagen
First posted: 2013-10-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Painscore during mobilization
timeFrame: 2-24 hours after extubation time.
Secondary outcomes:
measure: Painscore during rest
timeFrame: 2-24 hours after extubation time
measure: Morphine consumption
timeFrame: 0-24 hours after extubation time.
measure: Painscore during rest and mobilization
timeFrame: 48 hours after extubation time
measure: Degree of nausea
timeFrame: 2, 4, 8, 12, 24 and 48 hours after extubation time
measure: Incidence of vomiting
timeFrame: 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.
measure: Zofran consumption
timeFrame: 0-24 and 24-48 hours after extubation time.
measure: Degree of sedation
timeFrame: 2, 4, 8, 12, 24 and 48 hours after extubation time.
measure: Quality of sleep
timeFrame: 24 hours after extubation time.
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup University Hospital
Study officials:
affiliation: Glostrup University Hospital
name: Rikke Soennichsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Joergen B Dahl, MD
role: STUDY_CHAIR
References:
citation: Nielsen RV, Fomsgaard J, Mathiesen O, Dahl JB. The effect of preoperative dexamethasone on pain 1 year after lumbar disc surgery: a follow-up study. BMC Anesthesiol. 2016 Nov 16;16(1):112. doi: 10.1186/s12871-016-0277-z.
citation: Nielsen RV, Siegel H, Fomsgaard JS, Andersen JDH, Martusevicius R, Mathiesen O, Dahl JB. Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial. Pain. 2015 Dec;156(12):2538-2544. doi: 10.1097/j.pain.0000000000000326.