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

Phase 4

Completed

• Conditions: Hysterectomy; Methylprednisolone; Postoperative Pain
• Interventions: Drug: Methylprednisolone 125mg; Drug: Sodium Chloride 2 ml

• Registration Number: NCT01106547
• Lead Sponsor: Holbaek Sygehus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2011-09
• Status Verified: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-12
• Last Update Posted: 2011-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone	Methylprednisolone 125mg	-
placebo/sodium chloride	Sodium Chloride 2 ml	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Use of additional analgesics	0-2 days	The use of other analgesics than paracetamol and diclofenac postoperatively - dosage.
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
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.
Adverse effects	0-2 days
Inflammatory parameter	1-2 days postoperative	CRP measured at 10am on the first and second postoperative day.

Trial Locations

Locations (1)

Department of Gynaechology and Obstetrics, Holbæk Sygehus; 🇩🇰 Holbæk, Denmark