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The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106547
First Posted: April 20, 2010
Last Update Posted: October 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anna Aabakke, Holbaek Sygehus
April 14, 2010
April 20, 2010
October 13, 2011
August 2009
September 2011   (Final data collection date for primary outcome measure)
  • Pain 6 hours postoperatively [ Time Frame: 6 hours postoperatively ]
    Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 6 hours postoperatively
  • Pain 3 hours postoperatively [ Time Frame: 3 hours postoperatively ]
    Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 3 hours postoperatively
  • Pain 24 hours postoperatively [ Time Frame: 24 hours postoperatively ]
    Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 24 hours postoperatively
  • Pain [ Time Frame: 2-7 days postoperatively ]
    Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest once daily from 2nd-7th postoperative day
Same as current
Complete list of historical versions of study NCT01106547 on ClinicalTrials.gov Archive Site
  • Use of additional analgesics [ Time Frame: 0-2 days ]
    The use of other analgesics than paracetamol and diclofenac postoperatively - dosage.
  • Postoperative nausea [ Time Frame: until 2 days postoperatively ]
    Numbers of vomits
  • Use of antiemetics [ Time Frame: 0-2 days postoperatively ]
    Dosage of antiemetics during the first 2 days postoperatively
  • Time until mobilization [ Time Frame: 0-2 days ]
  • Time until discharge after surgery [ Time Frame: 0-10 days ]
  • Inflammatory parameters [ Time Frame: 0-24 h preoperatively ]
    CRP measured 0-24 hours preoperatively before injection of project medicine.
  • Adverse effects [ Time Frame: 0-2 days ]
  • Inflammatory parameter [ Time Frame: 1-2 days postoperative ]
    CRP measured at 10am on the first and second postoperative day.
Same as current
Not Provided
Not Provided
 
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study

The purpose of this study is to evaluate the effect of 125 mg methylprednisolone, given intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation after abdominal hysterectomy.Sodium Chloride is the placebo. The following parameters are registered:

  1. Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.
  2. The postoperative use of additional analgesics.
  3. Inflammatory parameters before and after surgery.
  4. Time until mobilization.
  5. Time until discharge.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Hysterectomy
  • Methylprednisolone
  • Postoperative Pain
  • Drug: Methylprednisolone 125mg
    Single dose 60-90 minutes preoperatively
    Other Name: Solu-medrol
  • Drug: Sodium Chloride 2 ml
    Single dose 60-90 min preoperatively
  • Experimental: Methylprednisolone
    Intervention: Drug: Methylprednisolone 125mg
  • Placebo Comparator: placebo/sodium chloride
    Intervention: Drug: Sodium Chloride 2 ml

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
October 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients having an abdominal hysterectomy on a benign indication.
  • Patients who speak and understand Danish.
  • Patients who can give informed consent.

Exclusion Criteria:

  • Diabetics
  • Regular use of glucocorticoids, opioids or tranquilizers
  • Regular treatment with immunosuppressives
  • Alcohol or drug abuse
  • Morphine intolerance
  • Age under 18
  • Chronic pain disease eg fibromyalgia, rheumatoid arthritis
  • Malign indication for hysterectomy
  • BMI over 35
  • Decreased kidney function
  • ASA III or IV
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01106547
Hysterektomistudiet
SJ-127 ( Other Identifier: The Danish National Committee on Biomedical Research Ethics )
2010-018448-15 ( EudraCT Number )
Yes
Not Provided
Not Provided
Anna Aabakke, Holbaek Sygehus
Holbaek Sygehus
Not Provided
Study Chair: Niels Jørgen Secher, Professor Department of Obstetrics, Hvidovre Hospital
Holbaek Sygehus
October 2011

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