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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Aabakke, Holbaek Sygehus
ClinicalTrials.gov Identifier:
NCT01106547
First received: April 14, 2010
Last updated: October 12, 2011
Last verified: October 2011

April 14, 2010
October 12, 2011
August 2009
September 2011   (final data collection date for primary outcome measure)
  • Pain 6 hours postoperatively [ Time Frame: 6 hours postoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The use of other analgesics than paracetamol and diclofenac postoperatively - dosage.
  • Postoperative nausea [ Time Frame: until 2 days postoperatively ] [ Designated as safety issue: No ]
    Numbers of vomits
  • Use of antiemetics [ Time Frame: 0-2 days postoperatively ] [ Designated as safety issue: No ]
    Dosage of antiemetics during the first 2 days postoperatively
  • Time until mobilization [ Time Frame: 0-2 days ] [ Designated as safety issue: No ]
  • Time until discharge after surgery [ Time Frame: 0-10 days ] [ Designated as safety issue: No ]
  • Inflammatory parameters [ Time Frame: 0-24 h preoperatively ] [ Designated as safety issue: No ]
    CRP measured 0-24 hours preoperatively before injection of project medicine.
  • Adverse effects [ Time Frame: 0-2 days ] [ Designated as safety issue: No ]
  • Inflammatory parameter [ Time Frame: 1-2 days postoperative ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01106547
Hysterektomistudiet, SJ-127, 2010-018448-15
Yes
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