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

NCT01953978 | Completed Phase 4 DMC

• 2 other identifiers: SM-RS-20122012-004181-18
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Analgesia; Postoperative; Dexamethasone; Spine surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  2-24 hours after extubation time.

Secondary Outcomes (8)

• Painscore during rest

  2-24 hours after extubation time

• Morphine consumption

  0-24 hours after extubation time.

• Painscore during rest and mobilization

  48 hours after extubation time

• Degree of nausea

  2, 4, 8, 12, 24 and 48 hours after extubation time

• Incidence of vomiting

  0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.

Study Arms (2)

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.

Drug: Dexamethasone; Drug: Morphine; Drug: Zofran; Drug: Paracetamol; Drug: Ibuprofen

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.

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

Interventions

Dexamethasone DRUG

Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation

Dexamethasone

Placebo OTHER

Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation

Placebo

Morphine DRUG

Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.

Dexamethasone; Placebo

Zofran DRUG

Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed

Dexamethasone; Placebo

Paracetamol DRUG

Tablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.

Dexamethasone; Placebo

Ibuprofen DRUG

Tablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.

Dexamethasone; Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (1)

Glostrup University Hospital

Glostrup Municipality, 2600, Denmark

Location

Related Publications (2)

• 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.

  PMID: 27852230 DERIVED

• 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.

  PMID: 26270586 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Dexamethasone; Morphine; Ondansetron; Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Rikke Soennichsen, MD

  Glostrup University Hospital

  PRINCIPAL INVESTIGATOR

• Joergen B Dahl, MD

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: December 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2015
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

DK (1)