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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Aabakke, Holbaek Sygehus
ClinicalTrials.gov Identifier:
NCT01106547
First received: April 14, 2010
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  Purpose

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.

Condition Intervention Phase
Hysterectomy
Methylprednisolone
Postoperative Pain
 Drug: Methylprednisolone 125mg
Drug: Sodium Chloride 2 ml
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Holbaek Sygehus:

Primary Outcome Measures:
  • Pain 6 hours postoperatively [ Time Frame: 6 hours postoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-2 days ] [ Designated as safety issue: No ]
    The use of other analgesics than paracetamol and diclofenac postoperatively - dosage.

  • Postoperative nausea [ Time Frame: until 2 days postoperatively ] [ Designated as safety issue: No ]
    Numbers of vomits

  • Use of antiemetics [ Time Frame: 0-2 days postoperatively ] [ Designated as safety issue: No ]
    Dosage of antiemetics during the first 2 days postoperatively

  • Time until mobilization [ Time Frame: 0-2 days ] [ Designated as safety issue: No ]
  • Time until discharge after surgery [ Time Frame: 0-10 days ] [ Designated as safety issue: No ]
  • Inflammatory parameters [ Time Frame: 0-24 h preoperatively ] [ Designated as safety issue: No ]
    CRP measured 0-24 hours preoperatively before injection of project medicine.

  • Adverse effects [ Time Frame: 0-2 days ] [ Designated as safety issue: No ]
  • Inflammatory parameter [ Time Frame: 1-2 days postoperative ] [ Designated as safety issue: No ]
    CRP measured at 10am on the first and second postoperative day.


Estimated Enrollment: 55
Study Start Date: August 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylprednisolone Drug: Methylprednisolone 125mg
Single dose 60-90 minutes preoperatively
Other Name: Solu-medrol
Placebo Comparator: placebo/sodium chloride Drug: Sodium Chloride 2 ml
Single dose 60-90 min preoperatively

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106547

Locations
Denmark
Department of Gynaechology and Obstetrics, Holbæk Sygehus
Holbæk, Denmark, 4300
Sponsors and Collaborators
Holbaek Sygehus
Investigators
Study Chair: Niels Jørgen Secher, Professor Department of Obstetrics, Hvidovre Hospital
  More Information

Publications:

Responsible Party: Anna Aabakke, Anna Aabakke, M.D., Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT01106547     History of Changes
Other Study ID Numbers: Hysterektomistudiet, SJ-127, 2010-018448-15
Study First Received: April 14, 2010
Last Updated: October 12, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency
Denmark: The GCP unit at Copenhagen University

Keywords provided by Holbaek Sygehus:
abdominal hysterectomy
glucocorticoids
rehabilitation
postoperative pain
analgetics

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013