The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy
|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.|
|ClinicalTrials.gov Identifier: NCT01106547|
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : October 13, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Hysterectomy Methylprednisolone Postoperative Pain||Drug: Methylprednisolone 125mg Drug: Sodium Chloride 2 ml||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||October 2011|
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
- 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.
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): NCT01106547
|Department of Gynaechology and Obstetrics, Holbæk Sygehus|
|Holbæk, Denmark, 4300|
|Study Chair:||Niels Jørgen Secher, Professor||Department of Obstetrics, Hvidovre Hospital|