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

October 12, 2011 updated by: Anna Aabakke, Holbaek Sygehus

The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Holbæk, Denmark, 4300
        • Department of Gynaechology and Obstetrics, Holbæk Sygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylprednisolone
Single dose 60-90 minutes preoperatively
Other Names:
  • Solu-medrol
Placebo Comparator: placebo/sodium chloride
Single dose 60-90 min preoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
2-7 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of additional analgesics
Time Frame: 0-2 days
The use of other analgesics than paracetamol and diclofenac postoperatively - dosage.
0-2 days
Postoperative nausea
Time Frame: until 2 days postoperatively
Numbers of vomits
until 2 days postoperatively
Use of antiemetics
Time Frame: 0-2 days postoperatively
Dosage of antiemetics during the first 2 days postoperatively
0-2 days postoperatively
Time until mobilization
Time Frame: 0-2 days
0-2 days
Time until discharge after surgery
Time Frame: 0-10 days
0-10 days
Inflammatory parameters
Time Frame: 0-24 h preoperatively
CRP measured 0-24 hours preoperatively before injection of project medicine.
0-24 h preoperatively
Adverse effects
Time Frame: 0-2 days
0-2 days
Inflammatory parameter
Time Frame: 1-2 days postoperative
CRP measured at 10am on the first and second postoperative day.
1-2 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Niels Jørgen Secher, Professor, Department of Obstetrics, Hvidovre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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