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Completed

NCT Number: NCT01106547

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

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.

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Key information

Conditions

Hysterectomy Methylprednisolone Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gynaechology and Obstetrics, Holbæk Sygehus

Holbæk, 4300, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone 125mg

Drug

Single dose 60-90 minutes preoperatively

Other names: Solu-medrol

Sodium Chloride 2 ml

Drug

Single dose 60-90 min preoperatively

Primary outcomes

  1. 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

  2. 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. 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

  4. 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

Secondary outcomes

  1. Use of additional analgesics

    Time frame: 0-2 days

    The use of other analgesics than paracetamol and diclofenac postoperatively - dosage.

  2. Postoperative nausea

    Time frame: until 2 days postoperatively

    Numbers of vomits

  3. Use of antiemetics

    Time frame: 0-2 days postoperatively

    Dosage of antiemetics during the first 2 days postoperatively

  4. Time until mobilization

    Time frame: 0-2 days

  5. Time until discharge after surgery

    Time frame: 0-10 days

  6. Inflammatory parameters

    Time frame: 0-24 h preoperatively

    CRP measured 0-24 hours preoperatively before injection of project medicine.

  7. Adverse effects

    Time frame: 0-2 days

  8. Inflammatory parameter

    Time frame: 1-2 days postoperative

    CRP measured at 10am on the first and second postoperative day.

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 20, 2010
Registry last updated
Oct 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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