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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2011

Interventions

  • Drug: Dexamethasone
    • single use of dexamethasone IV 8 mg/2 ml
  • Drug: Saline
    • 2 ml IV

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Saline
  • Active Comparator: Dexamethasone
    • Corticosteroid (Fortecontin 8 mg)

Clinical Trial Outcome Measures

Primary Measures

  • pain during coughing
    • Time Frame: day 1
    • Assessed with visual analog scale (VAS 0-100 mm)

Secondary Measures

  • 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)

Participating in This Clinical Trial

Inclusion Criteria

  • patients planned for elective laparoscopic hernia repair (TAPP) – Unilateral inguinal or femoral hernia – ASA class I-II – Read and speak Danish Exclusion Criteria:

  • Acute hernia operation – Operation for other hernias with mesh during the same procedure – Endocrine disease (diabetes, adrenal insufficiency etc.) – fever/infection within the first 10 days before operation – Poor compliance – No signed consent form – Daily intake of opioids or anxiolytic drugs – Manic episodes – Use medicine against glaucoma – Use thiazide or loop diuretics – Vaccination within the last 14 days

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mette Astrup Madsen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Mette Astrup Madsen, M.D. – Zealand University Hospital
  • Overall Official(s)
    • Mette A Tolver, M.D., Principal Investigator, University Hospital Koege
    • Thue Bisgaard, M.D. DMSc, Principal Investigator, University Hospital Koege

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