Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Jakob Kleif

Status and phase: Completed; Phase 2

Conditions: Suspected Appendicitis

Treatments: Drug: Methylprednisolone; Drug: 0.9% Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02711449

2015-004800-46 (EudraCT Number)

2015-810

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

Methylprednisolone

Experimental group

Description:

125 mg Methylprednisolone intravenously approximately 30 minutes prior to skin incision

Treatment:

Drug: Methylprednisolone

Placebo

Placebo Comparator group

Description:

0.9% Saline intravenously approximately 30 minutes prior to skin incision

Treatment:

Drug: 0.9% Saline