methylprednisolone
Drug125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision.
Other names: Solu-Medrol
NCT Number: NCT02711449
To test whether 125 mg preoperative methylprednisolone intravenously can reduce postoperative pain after laparoscopy for suspected appendicitis and to test whether preoperative methylprednisolone can reduce postoperative fatigue, increase quality of sleep, reduce nausea or vomiting, reduce duration of convalescence and increase overall quality of recovery after laparoscopy for suspected appendicitis.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Nordsjaellands Hospital, Hillerød, Denmark
Patients enrolled are randomized to active substance or placebo approximately 30 minutes prior to skin incision.
Patients are followed for 30 days postoperative with registration of outcomes on a postoperative questionnaire. Patients are contacted by telephone at every registration time. The primary outcome is also secured over the telephone in case patients do not return their questionnaire.
With a power of 80% and a significance level of 5% we need 64 patients (32 in each arm) to show a 30% reduction in postoperative pain during the first 3 postoperative days with 5 measurements and we need 42 patients (21 in each arm) to show a 15% increase in the QoR-15 during the first 3 postoperative days. With an anticipated loss to follow up of 20% we need 80 patients ( 40 in each arm).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision.
Other names: Solu-Medrol
0,9% Saline as an intravenously bolus injection approximately 30 minutes prior to skin incision.
Other names: Placebo
Time frame: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Powered to detect 30% reduction, Random regression model (mixed effects model)
Time frame: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Random regression model (mixed effects model)
Time frame: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Random regression model (mixed effects model)
Time frame: postoperative day (POD) 1, POD2 and POD3
Time frame: postoperative day (POD) 1, POD2 and POD3
Powered to detect 15% increase,
Time frame: 6 hours, 12 hours and 24-32 hours postoperative
Time frame: postoperative day (POD) 7, POD 14 and POD 30
Time frame: postoperative day (POD) 7, POD 14 and POD 30
Time frame: postoperative day (POD) 7, POD 14 and POD 30
Time frame: postoperative day (POD) 7, POD 14 and POD 30
Time frame: postoperative day (POD) 7, POD 14 and POD 30
Time frame: 6 hours, 12 hours and postoperative day 1
Time frame: Up to 60 days postoperative
Number of days from surgery until resumption of occupational activities
Time frame: Up to 60 days postoperative
Number of days from surgery until resumption of recreational activities
Time frame: Up to 60 days postoperative
Number of days from surgery until resumption of both occupational and recreational activities
Time frame: 30 day postoperative
Time frame: 30 day postoperative
Time frame: 24 hours postoperative
Both as a the need for opioids and the amount equivalent to intravenous morphine.
Time frame: 24 hours postoperative
Time frame: 30 days postoperative
The duration of the postoperative hospital stay in hours.
Jakob Kleif
Other
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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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View Trial Details