- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01106547
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:
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
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Holbæk, Denmark, 4300
- Department of Gynaechology and Obstetrics, Holbæk Sygehus
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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
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Single dose 60-90 minutes preoperatively
Other Names:
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Placebo Comparator: placebo/sodium chloride
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Single dose 60-90 min preoperatively
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain 6 hours postoperatively
Time Frame: 6 hours postoperatively
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Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 6 hours postoperatively
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6 hours postoperatively
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Pain 3 hours postoperatively
Time Frame: 3 hours postoperatively
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Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 3 hours postoperatively
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3 hours postoperatively
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Pain 24 hours postoperatively
Time Frame: 24 hours postoperatively
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Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 24 hours postoperatively
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24 hours postoperatively
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Pain
Time Frame: 2-7 days postoperatively
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Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest once daily from 2nd-7th postoperative day
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2-7 days postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of additional analgesics
Time Frame: 0-2 days
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The use of other analgesics than paracetamol and diclofenac postoperatively - dosage.
|
0-2 days
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Postoperative nausea
Time Frame: until 2 days postoperatively
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Numbers of vomits
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until 2 days postoperatively
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Use of antiemetics
Time Frame: 0-2 days postoperatively
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Dosage of antiemetics during the first 2 days postoperatively
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0-2 days postoperatively
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Time until mobilization
Time Frame: 0-2 days
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0-2 days
|
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Time until discharge after surgery
Time Frame: 0-10 days
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0-10 days
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Inflammatory parameters
Time Frame: 0-24 h preoperatively
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CRP measured 0-24 hours preoperatively before injection of project medicine.
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0-24 h preoperatively
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Adverse effects
Time Frame: 0-2 days
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0-2 days
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Inflammatory parameter
Time Frame: 1-2 days postoperative
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CRP measured at 10am on the first and second postoperative day.
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1-2 days postoperative
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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
- Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002 Nov;195(5):694-712. doi: 10.1016/s1072-7515(02)01491-6. No abstract available.
- Sauerland S, Nagelschmidt M, Mallmann P, Neugebauer EA. Risks and benefits of preoperative high dose methylprednisolone in surgical patients: a systematic review. Drug Saf. 2000 Nov;23(5):449-61. doi: 10.2165/00002018-200023050-00007.
- Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018.
- Henzi I, Walder B, Tramer MR. Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2000 Jan;90(1):186-94. doi: 10.1097/00000539-200001000-00038.
- Hall GM, Peerbhoy D, Shenkin A, Parker CJ, Salmon P. Relationship of the functional recovery after hip arthroplasty to the neuroendocrine and inflammatory responses. Br J Anaesth. 2001 Oct;87(4):537-42. doi: 10.1093/bja/87.4.537.
- Lidegaard O, Hammerum MS. Landspatientregisteret til kvalitetssikring i det gynækologiske speciale. 2002.
- Danish hysterektomy database - year report 2004.
- Wang JJ, Ho ST, Tzeng JI, Tang CS. The effect of timing of dexamethasone administration on its efficacy as a prophylactic antiemetic for postoperative nausea and vomiting. Anesth Analg. 2000 Jul;91(1):136-9. doi: 10.1097/00000539-200007000-00025.
- Liu K, Hsu CC, Chia YY. The effective dose of dexamethasone for antiemesis after major gynecological surgery. Anesth Analg. 1999 Nov;89(5):1316-8.
- Kehlet H. Glucocorticoids for peri-operative analgesia: how far are we from general recommendations? Acta Anaesthesiol Scand. 2007 Oct;51(9):1133-5. doi: 10.1111/j.1399-6576.2007.01459.x. No abstract available.
- Bisgaard T, Klarskov B, Kehlet H, Rosenberg J. Preoperative dexamethasone improves surgical outcome after laparoscopic cholecystectomy: a randomized double-blind placebo-controlled trial. Ann Surg. 2003 Nov;238(5):651-60. doi: 10.1097/01.sla.0000094390.82352.cb.
- Romundstad L, Breivik H, Niemi G, Helle A, Stubhaug A. Methylprednisolone intravenously 1 day after surgery has sustained analgesic and opioid-sparing effects. Acta Anaesthesiol Scand. 2004 Nov;48(10):1223-31. doi: 10.1111/j.1399-6576.2004.00480.x.
- Nagelschmidt M, Fu ZX, Saad S, Dimmeler S, Neugebauer E. Preoperative high dose methylprednisolone improves patients outcome after abdominal surgery. Eur J Surg. 1999 Oct;165(10):971-8. doi: 10.1080/110241599750008107.
- Mathiesen O, Rasmussen ML, Dierking G, Lech K, Hilsted KL, Fomsgaard JS, Lose G, Dahl JB. Pregabalin and dexamethasone in combination with paracetamol for postoperative pain control after abdominal hysterectomy. A randomized clinical trial. Acta Anaesthesiol Scand. 2009 Feb;53(2):227-35. doi: 10.1111/j.1399-6576.2008.01821.x. Epub 2008 Dec 6.
- Celik C, Tasdemir N, Abali R, Bastu E, Akbaba E, Yucel SH, Gul A. The effect of uterine straightening by bladder distention before outpatient hysteroscopy: a randomised clinical trial. Eur J Obstet Gynecol Reprod Biol. 2014 Sep;180:89-92. doi: 10.1016/j.ejogrb.2014.06.029. Epub 2014 Jul 7.
- Aabakke AJ, Holst LB, Jorgensen JC, Secher NJ. The effect of a preoperative single-dose methylprednisolone on postoperative pain after abdominal hysterectomy: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 Sep;180:83-8. doi: 10.1016/j.ejogrb.2014.06.026. Epub 2014 Jul 7.
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
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- Hysterektomistudiet
- SJ-127 (Other Identifier: The Danish National Committee on Biomedical Research Ethics)
- 2010-018448-15 (EudraCT Number)
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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