The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Methylprednisolone 125mg
- Conditions
- Hysterectomy
- Sponsor
- Holbaek Sygehus
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Pain 6 hours postoperatively
- Status
- Completed
- Last Updated
- 14 years ago
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.
Investigators
Anna Aabakke
Anna Aabakke, M.D.
Holbaek Sygehus
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
Arms & Interventions
Methylprednisolone
Intervention: Methylprednisolone 125mg
placebo/sodium chloride
Intervention: Sodium Chloride 2 ml
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Use of additional analgesics(0-2 days)
- Postoperative nausea(until 2 days postoperatively)
- Use of antiemetics(0-2 days postoperatively)
- Time until mobilization(0-2 days)
- Time until discharge after surgery(0-10 days)
- Inflammatory parameters(0-24 h preoperatively)
- Adverse effects(0-2 days)
- Inflammatory parameter(1-2 days postoperative)