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

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ClinicalTrials.gov Identifier: NCT01953978
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : October 27, 2015
Sponsor:
Collaborator:
Glostrup University Hospital, Copenhagen
Information provided by (Responsible Party):
Rikke Vibeke Nielsen, MD, Glostrup University Hospital, Copenhagen

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Dexamethasone Other: Placebo Drug: Morphine Drug: Zofran Drug: Paracetamol Drug: Ibuprofen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery
Study Start Date : December 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Active Comparator: Dexamethasone
  • 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
Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation

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

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

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

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

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

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

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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953978


Locations
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Denmark
Glostrup University Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
Rigshospitalet, Denmark
Glostrup University Hospital, Copenhagen
Investigators
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Principal Investigator: Rikke Soennichsen, MD Glostrup University Hospital
Study Chair: Joergen B Dahl, MD Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rikke Vibeke Nielsen, MD, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01953978     History of Changes
Other Study ID Numbers: SM-RS-2012
2012-004181-18 ( EudraCT Number )
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Rikke Vibeke Nielsen, MD, Glostrup University Hospital, Copenhagen:
Pain
Analgesia
Postoperative
Dexamethasone
Spine surgery

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Ibuprofen
Ondansetron
Morphine
Acetaminophen
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants