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

Holbaek Sygehus

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Methylprednisolone; Hysterectomy

Treatments: Drug: Methylprednisolone 125mg; Drug: Sodium Chloride 2 ml

Study type: Interventional

Funder types: Other

Identifiers

NCT01106547

Hysterektomistudiet

SJ-127 (Other Identifier)

2010-018448-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

Methylprednisolone

Experimental group

Treatment:

Drug: Methylprednisolone 125mg

placebo/sodium chloride

Placebo Comparator group

Treatment:

Drug: Sodium Chloride 2 ml