The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy
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:
- Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.
- The postoperative use of additional analgesics.
- Inflammatory parameters before and after surgery.
- Time until mobilization.
- Time until discharge.
|Hysterectomy Methylprednisolone Postoperative Pain||Drug: Methylprednisolone 125mg Drug: Sodium Chloride 2 ml||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study|
- 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
- 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.
|Study Start Date:||August 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Drug: Methylprednisolone 125mg
Single dose 60-90 minutes preoperatively
Other Name: Solu-medrol
|Placebo Comparator: placebo/sodium chloride||
Drug: Sodium Chloride 2 ml
Single dose 60-90 min preoperatively
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106547
|Department of Gynaechology and Obstetrics, Holbæk Sygehus|
|Holbæk, Denmark, 4300|
|Study Chair:||Niels Jørgen Secher, Professor||Department of Obstetrics, Hvidovre Hospital|