The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy
NCT ID: NCT01106547
Last Updated: 2011-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
55 participants
INTERVENTIONAL
2009-08-31
2011-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Methylprednisolone
Methylprednisolone 125mg
Single dose 60-90 minutes preoperatively
placebo/sodium chloride
Sodium Chloride 2 ml
Single dose 60-90 min preoperatively
Interventions
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Methylprednisolone 125mg
Single dose 60-90 minutes preoperatively
Sodium Chloride 2 ml
Single dose 60-90 min preoperatively
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who speak and understand Danish.
* Patients who can give informed consent.
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Holbaek Sygehus
OTHER
Responsible Party
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Anna Aabakke
Anna Aabakke, M.D.
Principal Investigators
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Niels Jørgen Secher, Professor
Role: STUDY_CHAIR
Department of Obstetrics, Hvidovre Hospital
Locations
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Department of Gynaechology and Obstetrics, Holbæk Sygehus
Holbæk, , Denmark
Countries
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References
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Lidegaard O, Hammerum MS. Landspatientregisteret til kvalitetssikring i det gynækologiske speciale. 2002.
Danish hysterektomy database - year report 2004.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SJ-127
Identifier Type: OTHER
Identifier Source: secondary_id
2010-018448-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Hysterektomistudiet
Identifier Type: -
Identifier Source: org_study_id