NCT02711449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

February 23, 2016

Last Update Submit

September 24, 2016

Conditions

Suspected Appendicitis

Keywords

acute surgerylaparoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Pain when coughing during the first 3 postoperative days on a 11-point NRS

    6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3

  • Fatigue during the first 3 postoperative days on a 11-point NRS

    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

    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

  • +14 more secondary outcomes

Study Arms (2)

Methylprednisolone

EXPERIMENTAL

125 mg Methylprednisolone intravenously approximately 30 minutes prior to skin incision

Drug: Methylprednisolone

Placebo

PLACEBO COMPARATOR

0.9% Saline intravenously approximately 30 minutes prior to skin incision

Drug: 0.9% Saline

Interventions

MethylprednisoloneDRUG

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

Also known as: Solu-Medrol
Methylprednisolone
0.9% SalineDRUG

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

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laparoscopy for suspected appendicitis
  • Age 18 years or older
  • American Society of Anesthesiologist (ASA) class I-III.
  • Gives written and oral consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nordsjaellands Hospital

Hillerød, Denmark

Location

Køge Sygehus

Køge, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 29605019DERIVED

  • 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.

    PMID: 29200067DERIVED

MeSH Terms

Interventions

MethylprednisoloneMethylprednisolone HemisuccinateSaline Solution

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jakob Kleif, M.D.

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 17, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

DK(2)