Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-09-30

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.

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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).

Conditions

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Suspected Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methylprednisolone

125 mg Methylprednisolone intravenously approximately 30 minutes prior to skin incision

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision.

Placebo

0.9% Saline intravenously approximately 30 minutes prior to skin incision

Group Type PLACEBO_COMPARATOR

0.9% Saline

Intervention Type DRUG

0,9% Saline as an intravenously bolus injection approximately 30 minutes prior to skin incision.

Interventions

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Methylprednisolone

125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision.

Intervention Type DRUG

0.9% Saline

0,9% Saline as an intravenously bolus injection approximately 30 minutes prior to skin incision.

Intervention Type DRUG

Other Intervention Names

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Solu-Medrol Placebo

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No