Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Conditions
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Suspected Appendicitis

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: 0.9% Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Laparoscopy for suspected appendicitis Age 18 years or older American Society of Anesthesiologist (ASA) class I-III. Gives written and oral consent Exclusion Criteria: Known inflammatory bowel disease. Known autoimmune disease. Chronic pain patient. Presumed poor compliance. Pregnant or breastfeeding. In systematic treatment with glucocorticoids or other immunosuppressive treatment. Known renal disease, GFR<30. Known liver cirrhosis. Known heart failure, EF<40%. Known glaucoma. Known ocular herpes simplex. Known cushings disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylprednisolone<br>125 mg Methylprednisolone intravenously approximately 30 minutes prior to skin incision | Drug: Methylprednisolone<br>* 125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision.<br>* Other names: Solu-Medrol;|
| Placebo Comparator: Placebo<br>0.9% Saline intravenously approximately 30 minutes prior to skin incision | Drug: 0.9% Saline<br>* 0,9% Saline as an intravenously bolus injection approximately 30 minutes prior to skin incision.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest during the first 3 postoperative days on a 11-point NRS | Powered to detect 30% reduction, Random regression model (mixed effects model) | 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain when coughing during the first 3 postoperative days on a 11-point NRS | Random regression model (mixed effects model) | 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3 | 
| Fatigue during the first 3 postoperative days on a 11-point NRS | Random regression model (mixed effects model) | 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3 | 
| Sleep during the first 3 postoperative days on a 11-point NRS |  | postoperative day (POD) 1, POD2 and POD3 | 
| QoR-15 during the first 3 postoperative days | Powered to detect 15% increase, | postoperative day (POD) 1, POD2 and POD3 | 
| Incidence of postoperative nausea or vomiting during the first postoperative day |  | 6 hours, 12 hours and 24-32 hours postoperative | 
| Pain at rest after POD3 on a 11-point NRS |  | postoperative day (POD) 7, POD 14 and POD 30 | 
| Pain when coughing after POD3 on a 11-point NRS |  | postoperative day (POD) 7, POD 14 and POD 30 | 
| Fatigue after POD3 on a 11-point NRS |  | postoperative day (POD) 7, POD 14 and POD 30 | 
| Sleep after POD3 on a 11-point NRS |  | postoperative day (POD) 7, POD 14 and POD 30 | 
| QoR-15 after POD 3 |  | postoperative day (POD) 7, POD 14 and POD 30 | 
| Mobilization during the first postoperative day on a 4-point likert scale |  | 6 hours, 12 hours and postoperative day 1 | 
| Resumption of occupational activity | Number of days from surgery until resumption of occupational activities | Up to 60 days postoperative | 
| Resumption of recreational activity | Number of days from surgery until resumption of recreational activities | Up to 60 days postoperative | 
| Duration of convalescence | Number of days from surgery until resumption of both occupational and recreational activities | Up to 60 days postoperative | 
| Adverse events according to GCP guidelines |  | 30 day postoperative | 
| Postoperative complications according to the Clavien-Dindo classification |  | 30 day postoperative | 
| Opioid consumption during the first 24 hours postoperative | Both as a the need for opioids and the amount equivalent to intravenous morphine. | 24 hours postoperative | 
| Need for rescue antiemetics during the first 24 hours postoperative |  | 24 hours postoperative | 
| Duration of postoperative hospital stay | The duration of the postoperative hospital stay in hours. | 30 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute surgery, laparoscopy