Clinical trial NCT02711449: Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy
Official title: Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Suspected Appendicitis
Keywords: acute surgery
laparoscopy
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2016-03-17
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pain at rest during the first 3 postoperative days on a 11-point NRS
timeFrame: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Secondary outcomes:
measure: Pain when coughing during the first 3 postoperative days on a 11-point NRS
timeFrame: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
measure: Fatigue during the first 3 postoperative days on a 11-point NRS
timeFrame: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
measure: Sleep during the first 3 postoperative days on a 11-point NRS
timeFrame: postoperative day (POD) 1, POD2 and POD3
measure: QoR-15 during the first 3 postoperative days
timeFrame: postoperative day (POD) 1, POD2 and POD3
measure: Incidence of postoperative nausea or vomiting during the first postoperative day
timeFrame: 6 hours, 12 hours and 24-32 hours postoperative
measure: Pain at rest after POD3 on a 11-point NRS
timeFrame: postoperative day (POD) 7, POD 14 and POD 30
measure: Pain when coughing after POD3 on a 11-point NRS
timeFrame: postoperative day (POD) 7, POD 14 and POD 30
measure: Fatigue after POD3 on a 11-point NRS
timeFrame: postoperative day (POD) 7, POD 14 and POD 30
measure: Sleep after POD3 on a 11-point NRS
timeFrame: postoperative day (POD) 7, POD 14 and POD 30
measure: QoR-15 after POD 3
timeFrame: postoperative day (POD) 7, POD 14 and POD 30
measure: Mobilization during the first postoperative day on a 4-point likert scale
timeFrame: 6 hours, 12 hours and postoperative day 1
measure: Resumption of occupational activity
timeFrame: Up to 60 days postoperative
measure: Resumption of recreational activity
timeFrame: Up to 60 days postoperative
measure: Duration of convalescence
timeFrame: Up to 60 days postoperative
measure: Adverse events according to GCP guidelines
timeFrame: 30 day postoperative
measure: Postoperative complications according to the Clavien-Dindo classification
timeFrame: 30 day postoperative
measure: Opioid consumption during the first 24 hours postoperative
timeFrame: 24 hours postoperative
measure: Need for rescue antiemetics during the first 24 hours postoperative
timeFrame: 24 hours postoperative
measure: Duration of postoperative hospital stay
timeFrame: 30 days postoperative
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjaellands Hospital
city: Køge
country: Denmark
facility: Køge Sygehus
Study officials:
affiliation: Nordsjaellands Hospital
name: Jakob Kleif, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21.
citation: Kleif J, Hauge CI, Vilandt J, Gogenur I. Randomized Clinical Trial of Preoperative High-Dose Methylprednisolone on Postoperative Pain at Rest After Laparoscopic Appendectomy. Anesth Analg. 2018 May;126(5):1712-1720. doi: 10.1213/ANE.0000000000002693.