Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SJ-127 | Other Identifier | The Danish National Committee on Biomedical Research Ethics | |
| 2010-018448-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Experimental |
| |
| placebo/sodium chloride | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone 125mg | Drug | Single dose 60-90 minutes preoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain 6 hours postoperatively | Pain registered by a score on a vas-scale from 0-10 during mobilization and during rest 6 hours postoperatively | 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 | 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 | 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 | 2-7 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Use of additional analgesics | The use of other analgesics than paracetamol and diclofenac postoperatively - dosage. | 0-2 days |
| Postoperative nausea | Numbers of vomits |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Niels Jørgen Secher, Professor | Department of Obstetrics, Hvidovre Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynaechology and Obstetrics, Holbæk Sygehus | Holbæk | 4300 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Lidegaard O, Hammerum MS. Landspatientregisteret til kvalitetssikring i det gynækologiske speciale. 2002. | ||
| Background | Danish hysterektomy database - year report 2004. | ||
| 11878721 | Background | 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. | |
| 10625002 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium Chloride 2 ml | Drug | Single dose 60-90 min preoperatively |
|
| until 2 days postoperatively |
| Use of antiemetics | Dosage of antiemetics during the first 2 days postoperatively | 0-2 days postoperatively |
| Time until mobilization | 0-2 days |
| Time until discharge after surgery | 0-10 days |
| Inflammatory parameters | CRP measured 0-24 hours preoperatively before injection of project medicine. | 0-24 h preoperatively |
| Adverse effects | 0-2 days |
| Inflammatory parameter | CRP measured at 10am on the first and second postoperative day. | 1-2 days postoperative |
| Background |
| 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. |
| 10866900 | Background | 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. |
| 10553859 | Background | 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. |
| 17850557 | Background | 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. |
| 16757774 | Background | 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. |
| 14578725 | Background | 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. |
| 15504180 | Background | 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. |
| 10574107 | Background | 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. |
| 12437261 | Background | 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. |
| 11085349 | Background | 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. |
| 19076108 | Background | 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. |
| 25058804 | Derived | 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. |
| 25058803 | Derived | 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. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D008776 | Methylprednisolone Hemisuccinate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided