Clinical Trial: Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair

Brief Summary: Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.

Detailed Summary:
Sponsor: Mette Astrup Madsen

Current Primary Outcome: pain during coughing [ Time Frame: day 1 ]

Assessed with visual analog scale (VAS 0-100 mm)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • pain during coughing [ Time Frame: 4 days ]
    Assessed with VAS
  • pain at rest [ Time Frame: 4 days ]
    Assessed with VAS
  • convalescence [ Time Frame: 1 month ]
    Registration of number of days after operation before returning to work and recreational activities.
  • pain at rest [ Time Frame: 4 days ]
    Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)
  • nausea [ Time Frame: 2 days ]
    Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)
  • vomiting [ Time Frame: 2 days ]
    yes/no question. If yes, how many times have you been vomiting?
  • discomfort [ Time Frame: 4 days ]
    Assessed with visual analog scale (VAS, 0-100 mm)
  • fatigue [ Time Frame: 4 days ]
    Assessed with numeric rating scale (NRS, 1-10)


Original Secondary Outcome:

  • pain during coughing [ Time Frame: 4 days ]
    Assessed with VAS
  • pain at rest [ Time Frame: 4 days ]
    Assessed with VAS
  • convalescence [ Time Frame: 1 month ]
    Registration of number of days after operation before returning to work and recreational activities.
  • pain at rest [ Time Frame: 4 days ]
    Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)
  • nausea [ Time Frame: 2 days ]
    Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)
  • vomiting [ Time Frame: 2 days ]
    yes/no question. If yes, how many times have you been vomiting?
  • general well-being [ Time Frame: 4 days ]
    Assessed with visual analog scale (VAS, 0-100 mm)
  • fatigue [ Time Frame: 4 days ]
    Assessed with numeric rating scale (NRS, 1-10)


Information By: University Hospital Koge

Dates:
Date Received: July 26, 2010
Date Started: August 2010
Date Completion:
Last Updated: January 26, 2012
Last Verified: January 2012