Skip to main content
OpenTrials
Completed

NCT Number: NCT01953978

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glostrup University Hospital

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

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

Placebo

Other

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

Morphine

Drug

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

Zofran

Drug

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

Paracetamol

Drug

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

Ibuprofen

Drug

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

Primary outcomes

  1. Painscore during mobilization

    Time frame: 2-24 hours after extubation time.

    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.

Secondary outcomes

  1. Painscore during rest

    Time frame: 2-24 hours after extubation time

    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.

  2. Morphine consumption

    Time frame: 0-24 hours after extubation time.

    Total morphine consumption 0-24 hours after extubation time, administered as patient controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes).

  3. Painscore during rest and mobilization

    Time frame: 48 hours after extubation time

    Painscore during rest and during active mobilization (VAS scale) at time 48 hours after extubation time.

  4. Degree of nausea

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

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

  5. Incidence of vomiting

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

    Total number of vomits 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.

  6. Zofran consumption

    Time frame: 0-24 and 24-48 hours after extubation time.

    Consumption of Zofran (milligram) 0-24 and 24-48 hours after extubation time.

  7. Degree of sedation

    Time frame: 2, 4, 8, 12, 24 and 48 hours after extubation time.

    Degree of sedation 2, 4, 8, 12, 24 and 48 hours after extubation time.

  8. Quality of sleep

    Time frame: 24 hours after extubation time.

    Quality of sleep 24 hours after extubation time.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Glostrup University Hospital, Copenhagen

Registry information

Official study title

The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Oct 1, 2013
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.