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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

Tracking Information
First Submitted Date  ICMJE September 26, 2013
First Posted Date  ICMJE October 1, 2013
Last Update Posted Date October 27, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01953978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
  • 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.
  • 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).
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • Quality of sleep [ Time Frame: 24 hours after extubation time. ]
    Quality of sleep 24 hours after extubation time.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery
Official Title  ICMJE The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Dexamethasone
    Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Dexamethasone
    • Drug: Morphine
    • Drug: Zofran
    • Drug: Paracetamol
    • Drug: Ibuprofen
  • 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.
    Interventions:
    • Other: Placebo
    • Drug: Morphine
    • Drug: Zofran
    • Drug: Paracetamol
    • Drug: Ibuprofen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2014)
160
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2013)
150
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01953978
Other Study ID Numbers  ICMJE SM-RS-2012
2012-004181-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rikke Vibeke Nielsen, MD, Glostrup University Hospital, Copenhagen
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Glostrup University Hospital, Copenhagen
Investigators  ICMJE
Principal Investigator: Rikke Soennichsen, MD Glostrup University Hospital
Study Chair: Joergen B Dahl, MD Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP