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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study

Conditions
-----------------
Hysterectomy, Methylprednisolone, Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Methylprednisolone 125mg
* Drug: Sodium Chloride 2 ml


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylprednisolone<br> | Drug: Methylprednisolone 125mg<br>* Single dose 60-90 minutes preoperatively<br>* Other names: Solu-medrol;|
| Placebo Comparator: placebo/sodium chloride<br> | Drug: Sodium Chloride 2 ml<br>* Single dose 60-90 min preoperatively<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 6 hours postoperatively | Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 6 hours postoperatively | 6 hours postoperatively | 
| Pain 3 hours postoperatively | Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 3 hours postoperatively | 3 hours postoperatively | 
| Pain 24 hours postoperatively | Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 24 hours postoperatively | 24 hours postoperatively | 
| Pain | Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest once daily from 2nd-7th postoperative day | 2-7 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of additional analgesics | The use of other analgesics than paracetamol and diclofenac postoperatively - dosage. | 0-2 days | 
| Postoperative nausea | Numbers of vomits | until 2 days postoperatively | 
| Use of antiemetics | Dosage of antiemetics during the first 2 days postoperatively | 0-2 days postoperatively | 
| Time until mobilization |  | 0-2 days | 
| Time until discharge after surgery |  | 0-10 days | 
| Inflammatory parameters | CRP measured 0-24 hours preoperatively before injection of project medicine. | 0-24 h preoperatively | 
| Adverse effects |  | 0-2 days | 
| Inflammatory parameter | CRP measured at 10am on the first and second postoperative day. | 1-2 days postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal hysterectomy, glucocorticoids, rehabilitation, postoperative pain, analgetics