Clinical trial NCT01106547: The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hysterectomy
Methylprednisolone
Postoperative Pain
Keywords: abdominal hysterectomy
glucocorticoids
rehabilitation
postoperative pain
analgetics
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
First posted: 2010-04-20
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.


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

Primary outcomes:
measure: Pain 6 hours postoperatively
timeFrame: 6 hours postoperatively
measure: Pain 3 hours postoperatively
timeFrame: 3 hours postoperatively
measure: Pain 24 hours postoperatively
timeFrame: 24 hours postoperatively
measure: Pain
timeFrame: 2-7 days postoperatively
Secondary outcomes:
measure: Use of additional analgesics
timeFrame: 0-2 days
measure: Postoperative nausea
timeFrame: until 2 days postoperatively
measure: Use of antiemetics
timeFrame: 0-2 days postoperatively
measure: Time until mobilization
timeFrame: 0-2 days
measure: Time until discharge after surgery
timeFrame: 0-10 days
measure: Inflammatory parameters
timeFrame: 0-24 h preoperatively
measure: Adverse effects
timeFrame: 0-2 days
measure: Inflammatory parameter
timeFrame: 1-2 days postoperative
Other outcomes:
Locations:
city: Holbæk
country: Denmark
facility: Department of Gynaechology and Obstetrics, Holbæk Sygehus
Study officials:
affiliation: Department of Obstetrics, Hvidovre Hospital
name: Niels Jørgen Secher, Professor
role: STUDY_CHAIR
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