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Completed

NCT Number: NCT02711449

Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nordsjaellands Hospital, Hillerød, Denmark

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methylprednisolone

Drug

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

Other names: Solu-Medrol

0.9% saline

Drug

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

Other names: Placebo

Primary outcomes

  1. Pain at rest during the first 3 postoperative days on a 11-point NRS

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

    Powered to detect 30% reduction, Random regression model (mixed effects model)

Secondary outcomes

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

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

    Random regression model (mixed effects model)

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

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

    Random regression model (mixed effects model)

  3. Sleep during the first 3 postoperative days on a 11-point NRS

    Time frame: postoperative day (POD) 1, POD2 and POD3

  4. QoR-15 during the first 3 postoperative days

    Time frame: postoperative day (POD) 1, POD2 and POD3

    Powered to detect 15% increase,

  5. Incidence of postoperative nausea or vomiting during the first postoperative day

    Time frame: 6 hours, 12 hours and 24-32 hours postoperative

  6. Pain at rest after POD3 on a 11-point NRS

    Time frame: postoperative day (POD) 7, POD 14 and POD 30

  7. Pain when coughing after POD3 on a 11-point NRS

    Time frame: postoperative day (POD) 7, POD 14 and POD 30

  8. Fatigue after POD3 on a 11-point NRS

    Time frame: postoperative day (POD) 7, POD 14 and POD 30

  9. Sleep after POD3 on a 11-point NRS

    Time frame: postoperative day (POD) 7, POD 14 and POD 30

  10. QoR-15 after POD 3

    Time frame: postoperative day (POD) 7, POD 14 and POD 30

  11. Mobilization during the first postoperative day on a 4-point likert scale

    Time frame: 6 hours, 12 hours and postoperative day 1

  12. Resumption of occupational activity

    Time frame: Up to 60 days postoperative

    Number of days from surgery until resumption of occupational activities

  13. Resumption of recreational activity

    Time frame: Up to 60 days postoperative

    Number of days from surgery until resumption of recreational activities

  14. Duration of convalescence

    Time frame: Up to 60 days postoperative

    Number of days from surgery until resumption of both occupational and recreational activities

  15. Adverse events according to GCP guidelines

    Time frame: 30 day postoperative

  16. Postoperative complications according to the Clavien-Dindo classification

    Time frame: 30 day postoperative

  17. Opioid consumption during the first 24 hours postoperative

    Time frame: 24 hours postoperative

    Both as a the need for opioids and the amount equivalent to intravenous morphine.

  18. Need for rescue antiemetics during the first 24 hours postoperative

    Time frame: 24 hours postoperative

  19. Duration of postoperative hospital stay

    Time frame: 30 days postoperative

    The duration of the postoperative hospital stay in hours.

Sponsors and collaborators

Lead sponsor

Jakob Kleif

Other

Collaborators

  • Zealand University Hospital

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2016
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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