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

Primary Purpose

Hysterectomy, Methylprednisolone, Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Methylprednisolone 125mg
Sodium Chloride 2 ml
Sponsored by
Holbaek Sygehus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hysterectomy focused on measuring abdominal hysterectomy, glucocorticoids, rehabilitation, postoperative pain, analgetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Department of Gynaechology and Obstetrics, Holbæk Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylprednisolone

placebo/sodium chloride

Arm Description

Outcomes

Primary Outcome Measures

Pain 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
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 3 hours postoperatively
Pain 24 hours postoperatively
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 24 hours postoperatively
Pain
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

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

Full Information

First Posted
April 14, 2010
Last Updated
October 12, 2011
Sponsor
Holbaek Sygehus
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1. Study Identification

Unique Protocol Identification Number
NCT01106547
Brief Title
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy
Official Title
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Holbaek Sygehus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysterectomy, Methylprednisolone, Postoperative Pain
Keywords
abdominal hysterectomy, glucocorticoids, rehabilitation, postoperative pain, analgetics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone
Arm Type
Experimental
Arm Title
placebo/sodium chloride
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone 125mg
Other Intervention Name(s)
Solu-medrol
Intervention Description
Single dose 60-90 minutes preoperatively
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 2 ml
Intervention Description
Single dose 60-90 min preoperatively
Primary Outcome Measure Information:
Title
Pain 6 hours postoperatively
Description
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 6 hours postoperatively
Time Frame
6 hours postoperatively
Title
Pain 3 hours postoperatively
Description
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 3 hours postoperatively
Time Frame
3 hours postoperatively
Title
Pain 24 hours postoperatively
Description
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 24 hours postoperatively
Time Frame
24 hours postoperatively
Title
Pain
Description
Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest once daily from 2nd-7th postoperative day
Time Frame
2-7 days postoperatively
Secondary Outcome Measure Information:
Title
Use of additional analgesics
Description
The use of other analgesics than paracetamol and diclofenac postoperatively - dosage.
Time Frame
0-2 days
Title
Postoperative nausea
Description
Numbers of vomits
Time Frame
until 2 days postoperatively
Title
Use of antiemetics
Description
Dosage of antiemetics during the first 2 days postoperatively
Time Frame
0-2 days postoperatively
Title
Time until mobilization
Time Frame
0-2 days
Title
Time until discharge after surgery
Time Frame
0-10 days
Title
Inflammatory parameters
Description
CRP measured 0-24 hours preoperatively before injection of project medicine.
Time Frame
0-24 h preoperatively
Title
Adverse effects
Time Frame
0-2 days
Title
Inflammatory parameter
Description
CRP measured at 10am on the first and second postoperative day.
Time Frame
1-2 days postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 ASA III or IV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Jørgen Secher, Professor
Organizational Affiliation
Department of Obstetrics, Hvidovre Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gynaechology and Obstetrics, Holbæk Sygehus
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark

12. IPD Sharing Statement

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

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