Hysterectomy, Methylprednisolone, Postoperative Pain
Conditions
Keywords
abdominal hysterectomy, glucocorticoids, rehabilitation, postoperative pain, analgetics
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.
Interventions
DRUGSodium Chloride 2 ml
Single dose 60-90 min preoperatively
DRUGMethylprednisolone 125mg
Single dose 60-90 minutes preoperatively
Sponsors
Holbaek Sygehus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain 6 hours postoperatively | 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 | 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 | 24 hours postoperatively | Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 24 hours postoperatively |
| Pain | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time until discharge after surgery | 0-10 days | — |
| Inflammatory parameters | 0-24 h preoperatively | CRP measured 0-24 hours preoperatively before injection of project medicine. |
| Use of additional analgesics | 0-2 days | The use of other analgesics than paracetamol and diclofenac postoperatively - dosage. |
| Inflammatory parameter | 1-2 days postoperative | CRP measured at 10am on the first and second postoperative day. |
| Adverse effects | 0-2 days | — |
| Postoperative nausea | until 2 days postoperatively | Numbers of vomits |
| Use of antiemetics | 0-2 days postoperatively | Dosage of antiemetics during the first 2 days postoperatively |
| Time until mobilization | 0-2 days | — |
Countries
Denmark
Outcome results
None listed